The Human Medicines Regulations 2012
PART 1
1Citation and commencement
2Medicinal products
3Scope of these Regulations: special provisions
4Special provisions for pharmacies etc
5Classification of medicinal products
6The licensing authority and the Ministers
7Advertisements relating to medicinal products
8General interpretation
PART 2
9Commission on Human Medicines
10Functions of the Commission
11British Pharmacopoeia Commission
12Reporting to Ministers
13Co-option of additional members of advisory bodies
14Appointment of expert advisory groups
15Delegation of functions to expert advisory groups
16Further provision about advisory bodies and expert advisory groups etc
PART 3
Grant etc of licences
17Manufacturing of medicinal products
18Wholesale dealing in medicinal products
19Exemptions from requirement for wholesale dealer’s licence
20Mixing of medicines
21Application for manufacturer’s or wholesale dealer’s licence
22Factors relevant to determination of application for manufacturer’s or wholesale dealer’s licence
23Grant or refusal of licence
24Standard provisions of licences
25Duration of licence
26General power to suspend, revoke or vary licences
27Procedure where licensing authority proposes to suspend, revoke or vary licence
28Suspension of licence in cases of urgency
29Variation of licence on the application of the holder
30Provision of information
Miscellaneous and offences
31Certification of manufacturer’s licence
32Sale and supply of starting materials
33Offence concerning data for advanced therapy medicinal products
34Offences: breach of regulations and false information and defence concerning starting materials
35Penalties
Conditions for holding a manufacturer’s licence
36Conditions for manufacturer’s licence
37Manufacturing and assembly
38Imports from states other than EEA States
39Further requirements for manufacturer’s licence
40Obligation to provide information relating to control methods
41Requirements as to qualified persons
Conditions for holding a wholesale dealer’s licence
42Conditions for wholesale dealer’s licence
43Obligations of licence holder
44Requirement for wholesale dealers to deal only with specified persons
45Requirement as to responsible persons
PART 4
46Requirement for authorisation
47Breach of requirement
PART 5
48Application of this Part
Application for UK marketing authorisation
49Application for grant of UK marketing authorisation
50Accompanying material
51Applications relating to generic medicinal products
52Applications relating to certain medicinal products that do not qualify as generic etc
53Applications relating to similar biological medicinal products
54Applications relating to products in well-established medicinal use
55Applications relating to new combinations of active substances
56Applications containing information supplied in relation to another product with consent
57Obligation to update information supplied in connection with application
Consideration of application
58Consideration of application
59Conditions of UK marketing authorisation: general
60Conditions of UK marketing authorisation: exceptional circumstances
61Conditions of UK marketing authorisation: new obligations post-authorisation
62Classification of UK marketing authorisation
63Frequency of periodic safety update reports
64Duties of licensing authority in connection with determination
Validity of UK marketing authorisation
65Validity of UK marketing authorisation
66Application for renewal of authorisation
67Failure to place on the market etc
Revocation, variation and suspension of marketing authorisation
68Revocation, variation and suspension of UK marketing authorisation
69Suspension of use etc of relevant medicinal product
70Authorisations granted under Chapter 4 of Title III of the 2001 Directive
71Withdrawal of medicinal product from the market
72Sale etc of suspended medicinal product
Obligations of holder of marketing authorisation
73Obligation to notify placing on the market etc
74Obligation to take account of scientific and technical progress
75Obligation to provide information relating to safety etc
76Obligation in relation to product information
77Record-keeping obligations
78Obligation to ensure appropriate and continued supplies
Offences relating to specific requirements
79Failure to provide information on marketing authorisations to EMA
80Urgent safety restrictions
Offences relating to EU marketing authorisations
81Obligation to update information supplied in connection with EU application
82EU marketing authorisations: failure to notify placing on market etc
83EU marketing authorisations: failure to take account of technical and scientific progress
84EU marketing authorisations: failure to provide information as to safety etc
85EU marketing authorisations: failure to update product information
86EU marketing authorisations: breach of pharmacovigilance condition etc
Offences relating to advanced therapy medicinal products
87Offences in connection with risk management systems and traceability systems
88Offence concerning data for advanced therapy medicinal products
Offences relating to the Paediatric Regulation
89Offences in connection with withdrawal of product from the market
90Failure to place on the market taking account of paediatric indication
91Failure to notify results of third country clinical trials
92Failure of sponsor of UK paediatric clinical trial to notify results of trial
93Failure to notify results of paediatric study
94Failure to submit report to EMA
General provisions relating to offences
95Offences in connection with application
96Provision of false or misleading information
97Breach of pharmacovigilance condition
98General offence of breach of provision of this Part
99Penalties
100Persons liable
101Defences
PART 6
Application of Part
102Application of Part
Application for certificate of registration and consideration of application
103Application for certificate of registration
104Consideration of application
105Conditions of certificate of registration
106Classification of certificate of registration
107Validity of certificate of registration
108Application for renewal of certificate
109Failure to place on the market etc
Revocation, variation and suspension of certificate of registration
110Revocation, variation and suspension of certificate of registration
111Certificates granted under Chapter 4 of Title III of the 2001 Directive
112Withdrawal of homoeopathic medicinal product from the market
Obligations of holder of certificate of registration
113Obligation to notify placing on the market etc
114Obligation to take account of scientific and technical progress
115Obligation to provide information relating to safety etc
116Obligation in relation to product information
117Record-keeping obligation
118Obligation to ensure appropriate and continued supplies
Provisions relating to offences
119Offences in connection with applications
120Provision of false or misleading information
121General offence of breach of provision of this Part
122Penalties
123Persons liable
124Defences
PART 7
Application of Part
125Traditional herbal medicinal products
126Addition of vitamins or minerals
Application for traditional herbal registration
127Application for grant of traditional herbal registration
128Accompanying material
129Obligation to update information supplied in connection with application
Consideration of application
130Consideration of application
131Classification of traditional herbal registration
Validity of traditional herbal registration
132Validity of traditional herbal registration
133Application for renewal of registration
134Failure to place on the market etc
Revocation, variation and suspension of traditional herbal registration
135Revocation, variation and suspension of traditional herbal registration
136Revocation by licensing authority: further provisions
137Procedures for revocation, variation or suspension
138Suspension of use etc of traditional herbal medicinal product
139Registrations granted under Chapter 4 of Title III of the 2001 Directive
140Withdrawal of traditional herbal medicinal product from the market
141Sale etc of suspended traditional herbal medicinal product
Obligations of holder of traditional herbal registration
142Obligation to notify placing on the market etc
143Obligation to take account of scientific and technical progress
144Obligation following new herbal monograph
145Obligation to provide information relating to safety etc
146Obligation in relation to product information
147Record-keeping obligations
148Obligation to ensure appropriate and continued supplies
Offences relating to traditional herbal registrations
149Urgent safety restrictions
150Offences in connection with applications
151Provision of false or misleading information
152General offence of breach of provision of this Part
153Penalties
154Persons liable
155Defences
PART 8
156Article 126a authorisations
157Requests from other member States
158Application of these Regulations
PART 9
159Provisional determination
160Challenge to provisional determination
161Written representations procedure
162Oral representations procedure
163Final determination without representations
164Effect of final determination
165Determination in other cases
166Offences relating to borderline products
PART 10etc
Exceptions
167Supply to fulfil special patient needs
168Use of non-prescription medicines in the course of a business
169Mixing of general sale medicinal products
170Record-keeping requirements
171Exempt advanced therapy medicinal products
172Parallel import licences
173Exemption for certain radiopharmaceuticals
174Supply in response to spread of pathogenic agents etc
Offences
175Offences relating to exceptions
176Penalties and supplementary provision about offences
PART 11
177Application of this Part and interpretation
Obligations on licensing authority in relation to pharmacovigilance
178General obligations of the licensing authority
179Obligation on licensing authority to operate pharmacovigilance system
180Obligation on licensing authority to audit pharmacovigilance system
181Delegation of obligations under this Part
Obligations on holders in relation to pharmacovigilance system
182Obligation on holder to operate pharmacovigilance system
183Exception to obligation to operate risk management system
184Obligation on holder to audit pharmacovigilance system
Recording, reporting and assessment of pharmacovigilance data
185Recording obligations on the licensing authority
186Reporting obligations on the licensing authority
187Recording obligations on holders
188Reporting obligations on holders
Signal detection
189Signal detection: licensing authority obligations
190Signal detection: holder obligation
Periodic Safety Update Reports
191Obligation on holder to submit periodic safety update reports: general requirements
192Obligation on holder to submit periodic safety update reports: derogation from general requirements
193Harmonisation of PSUR frequency or date of submission
194Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
195Obligation on licensing authority to assess PSURs where EU single assessment procedure does not apply
Urgent action
196Urgent action
197EU urgent action procedure
Post-authorisation safety studies
198Post-authorisation safety studies: general provisions
199Submission of draft study protocols for required studies
200Amendment to study protocols for required studies
201Submission and evaluation of final study reports for required studies
202Follow-up of final study reports
Transparency and communications
203Obligations on licensing authority in relation to national medicines web-portal
204Obligation on licensing authority in relation to public announcements
205Obligations on holders in relation to public announcements
Enforcement
206Infringement notices
207Offences
208False and misleading information
209Penalties
210Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004
211Persons liable
Transitional arrangements
212Transitional arrangements
PART 12
CHAPTER 1
213Interpretation
CHAPTER 2
Prescription only medicines
214Sale or supply of prescription only medicines
215Prescribing and administration by supplementary prescribers
216Exceptions to regulation 215
217Requirements for prescriptions: general
218Requirements for prescriptions: EEA health professionals
219Electronic prescriptions
Medicines not subject to general sale
220Sale or supply of medicinal products not subject to general sale
General sale medicines
221Sale or supply of medicinal products subject to general sale
222Sale of medicinal products from automatic machines
CHAPTER 3
Exemptions relating to supply in specific circumstances
223Exemptions for doctors and dentists etc
224Emergency sale etc by pharmacist: prescriber unable to provide prescription
225Emergency sale etc by pharmacist: at patient’s request
226Emergency sale etc by pharmacist: pandemic diseases
227Exemption for sale or supply in hospitals
228Exemptions relating to prescriptions given by certain health professionals
229Exemption for supply by national health service bodies
230Exemption for supply etc under a PGD to assist doctors or dentists
231Exemption for supply etc under a PGD by independent hospitals etc
232Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
233Exemption for supply etc under a PGD by person conducting a retail pharmacy business
234Exemption for supply etc of products under a PGD to assist the police etc
235Exemption for sale, supply or administration by certain persons
Exemptions in relation to specific kinds of product
236Products consisting of or containing aloxiprin, aspirin or paracetamol
237Products consisting of or containing pseudoephedrine salts or ephedrine base or salts
238Administration of certain medicines in an emergency
239Administration of smallpox vaccine
240Radioactive medicinal products
241Exemptions in respect of certain herbal remedies
242Exemption for medicinal products at high dilution
243Exemption for certain homoeopathic medicinal products
Other exemptions
244Exemption in cases involving another’s default
245Exemption in case of forged prescription
246Exemption where requirements for prescriptions not met
247Exemption for supply in the event or anticipation of pandemic disease
248Exemption for certain collection and delivery arrangements
CHAPTER 4
Miscellaneous provisions
249Restrictions on persons to be supplied with medicinal products
250Exceptions to regulation 249
251Compliance with standards specified in certain publications
252Compliance with standards specified in certain publications: supplementary
253Pharmacy records
254Prohibitions concerning traceability of treatment with advanced therapy medicinal products
255Offences relating to dealings with medicinal products
Disqualification
256Disqualification on conviction
PART 13
CHAPTER 1
Requirements for packaging and package leaflets relating to medicinal products
257Packaging requirements: general
258Packaging requirements: specific provisions
259Packaging requirements: information for blind and partially sighted patients
260Package leaflets
261Use of pictures and symbols etc
262Labelling requirements for radionuclides
263Leaflets relating to radionuclides
264Homoeopathic medicines
265Additional requirements for traditional herbal medicinal products
266Language requirements etc
267Submission of mock-ups of packaging and leaflets to licensing authority
Enforcement and offences
268Offence relating to packaging and package leaflets: holder of authorisation etc
269Offences relating to packaging and package leaflets: other persons
270Non-compliance with requirements of this Part
271Offences: penalties
CHAPTER 2
Requirements relating to child safety
272Interpretation
273Child resistant containers for regulated medicinal products
274Exemptions from regulation 273
275Colouring of aspirin and paracetamol products for children
276Offences
PART 14
CHAPTER 1
277Interpretation
278Functions of the Ministers
CHAPTER 2
General
279Products without a marketing authorisation etc
280General principles
281Duties of authorisation holders and registration holders
Advertising to the public
282Application of regulations 283 to 292
283Products for the purpose of inducing abortions
284Prescription only medicines
285Narcotic and psychotropic substances
286Material relating to diagnosis
287Material about effects of medicinal product
288Material about status of medicinal product
289Recommendations by scientists etc
290Advertisements directed at children
291Form and content of advertisement
292Exception for approved vaccination campaigns
Prohibition of supply to the public for promotional purposes
293Prohibition of supply to the public for promotional purposes
Advertising to persons qualified to prescribe or supply etc
294General requirements
295Abbreviated advertisements
296Exception for advertisements intended as a reminder
297Written material accompanying promotions
298Free samples for persons qualified to prescribe or supply medicinal products
299Medical sales representatives
300Inducements and hospitality
Homoeopathic medicinal products
301Advertisements for registered homoeopathic medicinal products
Traditional herbal medicinal products
302Advertisements for traditional herbal medicinal products
Offences
303Offences
CHAPTER 3
Scrutiny by Ministers
304Requirement to provide copy advertisement
305Invitation to make representations about compatibility
306Decision about compatibility
307Corrective statement
308Offences
Complaints to Ministers
309Complaints to Ministers: duty to consider
310Complaints to Ministers: power to refer
Injunctions
311Application for injunction
312Application for injunction: accuracy of factual claim
313Grant of injunction: publication of decision and corrective statement
Complaints to OFCOM
314Complaints to OFCOM
General
315Public interest etc
316Civil proceedings
PART 15
317British Pharmacopoeia and compendia
318Lists of names
319Other documents
320Supplementary provisions
321Specified publications
PART 16
322Validity of decisions and proceedings
323Enforcement in England, Wales and Scotland
324Enforcement in Northern Ireland
325Rights of entry
326Application for warrant
327Powers of inspection, sampling and seizure
328Regulation 327: supplementary
329Application of sampling procedure to substance or article seized under this Part
330Analysis of samples: other cases
331Findings and reports of inspections
332Restrictions on disclosure of information
333Protection for inspectors
334Supplementary provisions and offences
PART 17
Provisions relating to offences
335Contravention due to fault of another person
336Warranty as defence
337Offences in relation to warranties and certificates
338Offences by bodies corporate and partnerships
Prosecutions
339Prosecutions
General
340Presumptions
341Decisions under these Regulations
342Time limits for provision of information etc
343Service of documents
344Payment of expenses by Ministers
Immunity from civil liability
345Immunity from civil liability
Review
346Review
Transitional provisions, savings, amendments, repeals and revocations
347Transitional provisions and savings
348Amendments to existing law
349Repeals and revocations
SCHEDULES
SCHEDULE 1Further provisions for classification of medicinal products
PART 1Descriptions of certain medicinal products to be available only on prescription
1The following medicinal products shall be available only on prescription—...
2In this Part “cyanogenic substances” means preparations which—
PART 2Descriptions of certain medicinal products to be available only from a pharmacy
3The following medicinal products shall be available only from a...
4The following medicinal products shall be available only from a...
5A medicinal product shall be available only from a pharmacy...
SCHEDULE 2Supplementary provision relating to advisory bodies and expert advisory groups
Terms of appointment
1(1) The person appointed to chair an advisory body is...
2(1) A member of an advisory body, other than its...
3(1) The person appointed to chair an expert advisory group...
4(1) This paragraph applies to a member of an expert...
Facilities and proceedings
5The Ministers must provide each advisory body with such staff,...
6The validity of any proceedings of an advisory body or...
7(1) An advisory body may, subject to approval by the...
Payment and expenses
8The Ministers may pay to the members of each advisory...
9The Ministers must defray any expenses incurred with their approval...
10If an action is brought against a person arising out...
11Paragraphs 8 to 10 shall have effect in relation to...
Status
12An advisory body or expert advisory group is not to...
SCHEDULE 3Applications for licences under Part 3
Manufacturer’s licences
1(1) This paragraph applies to an application for a manufacturer’s...
Manufacturers’ licence relating to import
2(1) This paragraph applies to an application for a manufacturer’s...
Wholesale dealer’s licences
3(1) This paragraph applies to an application for a wholesale...
All licences
4(1) If an application does not include information or other...
SCHEDULE 4Standard provisions of licences under Part 3
PART 1Manufacturer’s licence relating to manufacture and assembly
1The provisions of this Part are standard provisions of a...
2The licence holder must place the quality control system referred...
3The licence holder may use a contract laboratory pursuant to...
4The licence holder must provide such information as may be...
5The licence holder must inform the licensing authority of any...
6The licence holder must— (a) keep readily available for inspection...
7The licence holder must keep readily available for examination by...
8Where the licence holder has been informed by the licensing...
9The licence holder must ensure that tests for determining conformity...
10Where the manufacturer’s licence relates to the assembly of a...
11Where— (a) the manufacturer’s licence relates to the assembly of...
12The licence holder must keep readily available for examination by...
13Where— (a) animals are used in the production of medicinal...
14The licence holder must take all reasonable precautions and exercise...
PART 2Manufacturer’s licence relating to the import of medicinal products from a state other than an EEA State
15The provisions of this Part are standard provisions of a...
16The licence holder must place the quality control system referred...
17The licence holder may use a contract laboratory pursuant to...
18The licence holder must provide such information as may be...
19The licence holder must— (a) keep readily available for inspection...
20Where the licence holder has been informed by the licensing...
21The licence holder must ensure that any tests for determining...
22(1) Where and in so far as the licence relates...
23The licence holder must take all reasonable precautions and exercise...
PART 3Manufacturer’s licence relating to exempt advanced therapy medicinal products
24The provisions of paragraphs 25 to 27 are incorporated as...
25The licence holder must ensure that the immediate packaging of...
26The licence holder must ensure that the package leaflet of...
27The licence holder must keep the data referred to in...
PART 4Wholesale dealer’s licence
All wholesale dealer’s licences
28The provisions of this Part are standard provisions of a...
29The licence holder must not use any premises for the...
30The licence holder must provide such information as may be...
31The licence holder must take all reasonable precautions and exercise...
Wholesale dealer’s licence relating to special medicinal products
32The provisions of paragraphs 33 to 42 are incorporated as...
33Where and in so far as the licence relates to...
34No later than 28 days prior to each importation of...
35The licence holder may not import the special medicinal product...
36The licence holder may import the special medicinal product referred...
37Where the licence holder sells or supplies special medicinal products,...
38The licence holder must not, on any one occasion, import...
39The licence holder must inform the licensing authority immediately of...
40The licence holder must not publish any advertisement, catalogue, or...
41The licence holder must cease importing or supplying a special...
42In this Part— “British approved name” means the name which...
Wholesale dealer’s licence relating to exempt advanced therapy medicinal products
43The provisions of paragraph 44 are incorporated as additional standard...
44The licence holder shall keep the data referred to in...
SCHEDULE 5Review upon oral representations
Application of this Schedule
1(1) This Schedule applies if a person (“the applicant”) mentioned...
Appointment of reviewers
2(1) The licensing authority must— (a) appoint a panel of...
Procedure before hearing
3(1) The applicant must supply the reviewers with a written...
Procedure at hearing
4(1) Both the applicant and the licensing authority may make...
Procedure following hearing
5(1) After the hearing the reviewers must provide a report...
SCHEDULE 6Manufacturer’s and wholesale dealer’s licences for exempt advanced therapy medicinal products
PART 1Manufacturer’s licences
1The requirements in paragraphs 2 to 12 apply to a...
2The licence holder must inform the licensing authority of any...
3The licence holder must ensure, if using human cells or...
4The licence holder must ensure that any human tissue or...
5The licence holder must ensure that any blood or blood...
6Where the holder of a manufacturer’s licence distributes by way...
7The licence holder must, at the written request of the...
8The licence holder must establish and maintain a system ensuring...
9The licence holder must, subject to paragraph 27 of Schedule...
10The licence holder must secure that the data referred to...
11The licence holder must, where an exempt advanced therapy medicinal...
12The licence holder must not import or export any exempt...
PART 2Wholesale dealer’s licences
13The requirements in paragraphs 14 to 20 apply to a...
14The licence holder must obtain supplies of exempt advanced therapy...
15The licence holder must distribute an exempt advanced therapy medicinal...
16The licence holder must establish and maintain a system ensuring...
17The licence holder must inform the licensing authority of any...
18The licence holder must, subject to paragraph 44 of Schedule...
19The licence holder must secure that the data referred to...
20The licence holder must not import or export any exempt...
SCHEDULE 7Qualified persons
PART 1Qualification requirements for qualified person
1A person must satisfy the requirements in paragraphs 2 and...
2The person must have a degree, diploma or other formal...
3A qualification satisfies the requirements of this Part if it...
4(1) A course should include at least the following core...
5If the course referred to in paragraph 3 is followed...
6If two university courses, or courses recognised as of university...
7If the person’s formal qualifications do not satisfy the requirements...
8(1) The person must (subject to sub-paragraph (2)) have at...
PART 2Qualified persons with long experience
9(1) This paragraph applies to a person who has acted...
10(1) This paragraph applies to a person who—
11If a person to whom paragraph 10 applies acquired the...
PART 3Obligations of qualified person
12The qualified person is responsible for securing—
13(1) This paragraph applies where— (a) a medicinal product which...
14(1) This paragraph applies where— (a) medicinal products are imported...
15(1) The qualified person is responsible for ensuring, in relation...
SCHEDULE 8Material to accompany an application for a UK marketing authorisation
PART 1General requirements
1The name or corporate name and permanent address of the...
2The name of the medicinal product. This may be—
3Qualitative and quantitative particulars of the constituents of the medicinal...
4An evaluation of the potential environmental risks posed by the...
5A description of the methods of manufacturing the medicinal product....
6The therapeutic indications and contra-indications for the medicinal product and...
7The posology and pharmaceutical form of the medicinal product, its...
8The reasons for any precautionary and safety measures to be...
9A description of the control methods employed by the manufacturer....
10The results of the following in relation to the medicinal...
11A detailed summary of those results prepared and signed by...
12A summary of the applicant’s pharmacovigilance system which shall include...
13The risk management plan, together with a summary, that—
14Where any clinical trials have been carried out outside the...
15A summary of the product characteristics for the medicinal product...
16A mock-up, in accordance with Part 13 (packaging and leaflets)...
17A document showing that the manufacturer of the medicinal product...
18Where an application for authorisation for the medicinal product to...
19Where an authorisation for the medicinal product to be placed...
20Where an authorisation for the medicinal product to be placed...
21Where an authorisation for the medicinal product to be placed...
22A copy of any designation of the medicinal product as...
PART 2Summary of the product characteristics
SCHEDULE 9Undertakings by non-EEA manufacturers
1The manufacturer must provide and maintain such staff, premises and...
2The manufacturer must provide and maintain such staff, premises, equipment...
3The manufacturer must provide and maintain a designated quality control...
4The manufacturer must conduct all manufacture and assembly operations in...
5The manufacturer must maintain an effective pharmaceutical quality assurance system...
6Where animals are used in the production of any medicinal...
7The manufacturer must make such adequate and suitable arrangements as...
8The manufacturer must inform the holder of the marketing authorisation...
9(1) The manufacturer shall keep readily available for inspection by...
10The manufacturer must keep readily available for examination by a...
11(1) The manufacturer must implement a system for recording and...
12The manufacturer must inform the holder of the marketing authorisation...
SCHEDULE 10National homoeopathic products
Meaning of “national homoeopathic product”
1(1) In this Schedule “national homoeopathic product” means a homoeopathic...
General requirements for application
2(1) An application for the grant of a UK marketing...
Requirement to submit safety data
3(1) The applicant must submit data as to the safety...
Exceptions to requirement to submit safety data
4(1) The applicant does not need to submit data as...
Requirement to submit efficacy data
5(1) The applicant must submit data as to the efficacy...
SCHEDULE 11Advice and representations
PART 1General procedures
Application of this Part
1(1) This Part of this Schedule applies to—
Requirement to consult the appropriate committee
2(1) The licensing authority must consult the appropriate committee if...
Exceptions to requirement to consult
3(1) Paragraph 2 does not apply to a proposal to...
4(1) Paragraph 2 does not apply to a proposal to...
Provisional opinion against authorisation
5(1) If the appropriate committee is consulted under paragraph 2(1)...
Opportunity to make representations
6(1) An applicant or holder notified under paragraph 5 may,...
Written representations
7(1) If the applicant or holder requests the opportunity to...
Oral representations
8(1) If the applicant or holder requests the opportunity to...
Other decisions of the appropriate committee
9(1) This paragraph applies if the applicant or holder—
Decision of licensing authority
10(1) After receiving the appropriate committee’s report under paragraph 7...
Right to review after paragraph 10 notification
11(1) A person to whom a notification is given under...
Licensing authority decisions in other cases
12(1) This paragraph applies if the appropriate committee has not...
Right to review or representations after paragraph 12 notification
13(1) A person to whom a notification is given under...
PART 2Type II variation applications, complex variation applications and new excipient variation applications
Application of this Part
14This Part applies— (a) to an application (a “Type II...
15(1) In paragraph 14(b)(i) “complex variation application” means an application...
16(1) In paragraph 14(b)(ii) “new excipient variation application” means an...
17This Part is subject to Part 4 of this Schedule....
Opportunity to make representations
18(1) This paragraph applies if the licensing authority notifies the...
Written representations
19(1) If the applicant requests the opportunity to make written...
Oral representations
20(1) If the applicant requests the opportunity to make oral...
Other decisions of the appropriate committee
21(1) This paragraph applies if the applicant—
Decision of licensing authority following report
22(1) After receiving the appropriate committee’s report under paragraph 19...
Right to review after paragraph 22 notification
23(1) This paragraph applies if the licensing authority notifies the...
PART 3Referral to the Committee for Herbal Medicinal Products
Application of this Part
24(1) This Part applies if the licensing authority proposes to...
Opportunity to make representations
25(1) The licensing authority must notify the applicant of the...
Written representations
26(1) If the applicant requests the opportunity to make written...
Oral representations
27(1) If the applicant requests the opportunity to make oral...
Other decisions of the appropriate committee
28(1) This paragraph applies if the applicant—
Decision of licensing authority following report
29(1) After receiving the appropriate committee’s report under paragraph 26...
Right to review after paragraph 29 notification
30(1) This paragraph applies if the licensing authority notifies the...
PART 4Exceptions to Schedule
31This Schedule does not apply to an application for the...
32This Schedule does not apply to an application for the...
33This Schedule ceases to apply if at any time the...
34This Schedule does not apply to an application for a...
35This Schedule does not apply to an application for a...
36This Schedule does not apply if the application or proposal...
37This Schedule does not apply if the application or proposal...
38This Schedule does not apply if the application or proposal...
39This Schedule does not apply if— (a) the licensing authority...
SCHEDULE 12Material to accompany an application for a traditional herbal registration
PART 1General requirements
1The name or corporate name and permanent address of the...
2The name of the medicinal product. This may be—
3Qualitative and quantitative particulars of the constituents of the medicinal...
4An evaluation of the potential environmental risks posed by the...
5A description of the methods of manufacturing the medicinal product....
6The therapeutic indications and contra-indications for the medicinal product and...
7The posology and pharmaceutical form of the medicinal product, its...
8The reasons for any precautionary and safety measures to be...
9A description of the control methods employed by the manufacturer....
10Results of pre-clinical (toxicological and pharmacological) tests in relation to...
11A detailed summary of those results prepared and signed by...
12A summary of the product characteristics for the medicinal product...
13A mock-up, in accordance with Part 13 (packaging and leaflets)...
14A document showing that the manufacturer of the medicinal product...
15Where the medicinal product consists of a combination of one...
16Details of any authorisation or registration obtained by the applicant...
17Details of any decision in another member State or a...
18Bibliographical or expert evidence of the traditional use of the...
19A bibliographic review of safety data.
20An expert report on safety.
PART 2Summary of the product characteristics
SCHEDULE 13Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners
SCHEDULE 14Prescription etc by supplementary prescribers: particulars of clinical management plan
SCHEDULE 15Requirements for specific products subject to general sale
1A medicinal product that contains aloxiprin, aspirin or paracetamol (or,...
2A medicinal product that contains ibuprofen and that is in...
SCHEDULE 16Patient group directions
PART 1Particulars to be included in a patient group direction
1The period during which the direction is to have effect....
2The description or class of medicinal product to which the...
3The clinical situations which medicinal products of that description or...
4Whether there are any restrictions on the quantity of medicinal...
5The clinical criteria under which a person is to be...
6Whether any class of person is excluded from treatment under...
7Whether there are circumstances in which further advice should be...
8The pharmaceutical form or forms in which medicinal products of...
9The strength, or maximum strength, at which medicinal products of...
10The applicable dosage or maximum dosage.
11The route of administration.
12The frequency of administration.
13Any minimum or maximum period of administration applicable to medicinal...
14Whether there are any relevant warnings to note and, if...
15Whether there is any follow up action to be taken...
16Arrangements for referral for medical advice.
17Details of the records to be kept of the supply,...
PART 2Persons on whose behalf a patient group Direction must be signed
PART 3Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed
PART 4Classes of individuals by whom supplies may be made
SCHEDULE 17Exemption for sale, supply or administration by certain persons
PART 1Exemption from restrictions on sale and supply of prescription only medicines
PART 2Exemption from the restriction on supply of prescription only medicines
PART 3Exemptions from the restriction on administration of prescription only medicines
PART 4Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products
PART 5Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products
SCHEDULE 18Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225
SCHEDULE 19Medicinal products for parenteral administration in an emergency
SCHEDULE 20Herbal medicinal products specified for the purposes of regulation 241
PART 1
PART 2
SCHEDULE 21Medicinal products at high dilutions
PART 1Dilutions of unit preparations diluted to at least one part in a thousand (3x)
PART 2Dilutions of unit preparations diluted to at least one part in a million (6x)
PART 3Dilutions of unit preparations diluted to at least one part in ten (1x)
PART 4Dilutions of unit preparations diluted to at least one part in ten (1x) for external use
SCHEDULE 22Classes of person for the purposes of regulation 249
SCHEDULE 23Particulars in pharmacy records
1Paragraph 2 applies, subject to paragraph 3, where the sale...
2In such a case, the particulars referred to in regulation...
3Where the sale or supply is in pursuance of a...
4Where the sale or supply of a prescription only medicine...
5Paragraph 6 applies where— (a) the sale or supply of...
6In such a case, the particulars referred to in regulation...
SCHEDULE 24Packaging information requirements
PART 1Outer and immediate packaging
1The name of the medicinal product.
2The strength and pharmaceutical form of the product.
3Where appropriate, whether the product is intended for babies, children...
4Where the product contains up to three active substances, the...
5A statement of the active substances in the product, expressed...
6The pharmaceutical form and the contents by weight, by volume...
7A list of— (a) where the product is injectable or...
8The method of administration of the product and if necessary...
9Where appropriate, space for the prescribed dose to be indicated....
10A warning that the product must be stored out of...
11Any special warning applicable to the product.
12The product’s expiry date (month and year), in clear terms....
13Any special storage precautions relating to the product.
14Any special precautions relating to the disposal of an unused...
15The name and address of the holder of the marketing...
16The number of the marketing authorisation, Article 126a authorisation or...
17The manufacturer’s batch number.
18In the case of a product that is not a...
PART 2Immediate packaging: blister packs
19The name of the medicinal product.
20The strength and pharmaceutical form of the product.
21Where appropriate, whether the product is intended for babies, children...
22Where the product contains up to three active substances, the...
23The name of the holder of the marketing authorisation, Article...
24The product’s expiry date (month and year), in clear terms....
25The manufacturer’s batch number.
PART 3Immediate packaging: small packages
26The name of the medicinal product.
27The strength and pharmaceutical form of the product.
28Where appropriate, whether the product is intended for babies, children...
29Where the product contains up to three active substances, the...
30The method of administration of the product and if necessary...
31The product’s expiry date (month and year), in clear terms....
32The manufacturer’s batch number.
33The contents of the packaging by weight, by volume or...
SCHEDULE 25Packaging requirements: specific provisions
PART 1Medicines on prescription
1Where the product is to be administered to a particular...
2The name and address of the person who sells or...
3The date on which the product is sold or supplied....
4Unless paragraph 5, applies, such of the following particulars as...
5This paragraph applies if the pharmacist, in the exercise of...
6Where paragraph 5 applies, the pharmacist may include such particulars,...
PART 2Transport, delivery and storage
7Any special requirements for the storage and handling of the...
8The expiry date of the product.
9The manufacturer’s batch number.
PART 3Pharmacy and prescription only medicines
10Paragraph 11 applies if a pharmacy medicine is—
11Where this paragraph applies, the capital letter “P” within a...
12Paragraph 13 applies if a prescription only medicine is—
13Where this paragraph applies, the capital letters “POM” within a...
PART 4Medicines containing paracetamol
14If the product contains paracetamol, except where the name of...
15If the product contains paracetamol the words “Do not take...
16If the product contains paracetamol, unless the product is wholly...
17If the product contains paracetamol and is wholly or mainly...
18If the product is required by this Part of this...
SCHEDULE 26Packaging requirements: special provisions
PART 1Supply by doctors, dentists, nurses and midwives
1Where the product is to be administered to a particular...
2The name and address of the person who sells or...
3The date on which the product is sold or supplied....
4Such of the following particulars as the person under whose...
PART 2Pharmacy exceptions
5Where the product is to be administered to a particular...
6The name and address of the person who sells or...
7The date on which the product is sold or supplied....
8Where the product is prescribed by an appropriate practitioner, such...
9This paragraph applies if a pharmacist, in the exercise of...
10Where paragraph 9 applies, the pharmacist may include such particulars,...
11Where the product is not prescribed by an appropriate practitioner,...
SCHEDULE 27Package leaflets
PART 1General requirements
1The name of the medicinal product.
2The strength and pharmaceutical form of the product.
3Where appropriate, whether the product is intended for babies, children...
4Where the product contains up to three active substances, the...
5The pharmaco-therapeutic group, or type of activity, of the product,...
6The product’s therapeutic indications.
7A list of— (a) contra-indications; (b) appropriate precautions for use;...
8The list mentioned in paragraph 7 must—
9Instructions for proper use of the product including in particular—...
10A description of the adverse reactions which may occur in...
11A reference to the expiry date printed on the packaging...
12Where the product is authorised under different names in different...
13For medicinal products included in the list referred to in...
14The statement: “Also you can help to make sure that...
15The date on which the package leaflet was last revised....
PART 2Paracetamol
16If a medicinal product contains paracetamol, unless the product is...
17If a medicinal product contains paracetamol and is wholly or...
SCHEDULE 28Labelling requirements for registrable homoeopathic medicinal products
PART 1Outer and immediate packaging
1The scientific name of the stock or stocks (which may...
2The name and address of the holder of the certificate...
3The method and, if necessary, route of administration.
4The product’s expiry date (month and year), in clear terms....
5The product’s pharmaceutical form.
6The contents of the presentation, specified by weight, volume or...
7Special storage precautions, if any.
8A special warning, if necessary in relation to the product....
9The manufacturer’s batch number.
10The number of the certificate of registration.
11The words “homoeopathic medicinal product without therapeutic indications”.
12A warning advising the user to consult a doctor if...
PART 2Blister packs etc contained in outer packaging
13The scientific name of the stock or stocks (which may...
14The name and address of the holder of the certificate...
15The product’s expiry date (month and year), in clear terms....
16The manufacturer’s batch number.
17The words “homoeopathic medicinal product without therapeutic indications”.
PART 3Small immediate packaging
18The scientific name of the stock or stocks (which may...
19The name and address of the holder of the certificate...
20The method and, if necessary, route of administration.
21The product’s expiry date (month and year), in clear terms....
22The contents of the presentation, specified by weight, volume or...
23The manufacturer’s batch number.
24The words “homoeopathic medicinal product without therapeutic indications”.
SCHEDULE 29Labelling of traditional herbal medicinal products
PART 1Traditional herbal medicinal products: general
1A statement to the effect that the product is a...
2A statement that the user should consult a doctor or...
PART 2Traditional herbal medicinal products not subject to general sale
3Subject to the provisions of regulation 265(2), paragraph 4 applies...
4Where this paragraph applies, the outer packaging and the immediate...
SCHEDULE 30Particulars for advertisements to persons qualified to prescribe or supply
1The number of the marketing authorisation, certificate of registration, traditional...
2The name and address of the holder of the marketing...
3The classification of the medicinal product as—
4The name of the medicinal product.
5A list of the active ingredients of the medicinal product...
6One or more of the indications for the medicinal product...
7A succinct statement of the entries (if any) in the...
8The cost excluding value added tax of—
9(1) The particulars specified in paragraph 7 must be printed...
SCHEDULE 31Sampling
Introductory
1(1) This Schedule has effect where a person authorised by...
Division of sample
2The sampling officer must as soon as practicable—
3If the sample was purchased by the sampling officer otherwise...
4If the sampling officer obtained the sample from a vending...
5If the sample is a sample of goods consigned from...
6If, in a case not falling within any of paragraphs...
7If, in a case not falling within any of paragraphs...
8In any case not falling within any of paragraphs 3...
9In every case falling within any of paragraphs 3 to...
10Unless the sampling officer decides not to submit the sample...
11If a sample consists of substances or articles in unopened...
12Regulation 343(1)(a) to (d) has effect in relation to supplying...
13If after reasonable inquiry the sampling officer is unable to...
Notice to person named on container
14(1) This paragraph applies where the sampling officer has obtained...
Analysis or other examination
15Where the enforcing authority that authorises the sampling officer is...
16Where any other enforcing authority authorises the sampling officer, if...
17(1) Arrangements of the kind mentioned in paragraphs 15(b) and...
18A laboratory to which a sample is submitted under paragraph...
19A laboratory that has analysed or examined a sample submitted...
20A person to whom a part of the sample is...
Provisions as to evidence
21(1) In proceedings for an offence under these Regulations, a...
22In proceedings for an offence under these Regulations, a document...
23(1) If, in proceedings before a magistrates’ court for an...
Analysis under direction of court
24(1) This paragraph applies where proceedings for an offence under...
25The costs of analysis or examination under paragraph 24 are...
Proof by written statement
26(1) In relation to England and Wales section 9 of...
Payment for sample taken under compulsory powers
27(1) Where a sampling officer takes a sample in the...
SCHEDULE 32Transitional provisions and savings
Continuity of the law
1(1) This paragraph applies where any provision of these Regulations...
Product licences
2(1) This paragraph applies to a marketing authorisation that—
Product licences of right
3(1) This paragraph applies to a product licence of right....
Classification of UK marketing authorisation and certificate of registration
4(1) Sub-paragraph (3) applies to a UK marketing authorisation granted...
Advanced therapy medicinal products
5No provision of these Regulations that applies only to advanced...
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)
6Regulation 9 (amendment of the Medicines for Human Use (Clinical...
Section 60 of the Medicines Act 1968 etc
7(1) Section 60 of the Medicines Act 1968 (“the Act”)...
SCHEDULE 33Transitional arrangements: pharmacovigilance
1Pharmacovigilance system master file
2Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (EC)...
3Post-authorisation safety studies
4Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...
5Reporting obligations
6The references to “the Eudravigilance database” in regulation 188(1)(a) and...
7The licensing authority must ensure that all reports and updated...
8Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...
9Periodic safety update reports
10The reference to “the EMA” in regulations 191(1) (obligation on...
SCHEDULE 34Amendments to existing law
PART 1The Medicines Acts 1968 and 1971
1The Medicines Act 1968 is amended as follows.
2For the text of section 1 (Ministers responsible for the...
3In section 10 (exemptions for pharmacists)— (a) in subsection (1)...
4In section 15 (provision for extending or modifying exemptions)—
5In section 58 (medicinal products on prescription only)—
6In section 58A(1) (requirement to specify certain products as prescription-only...
7In section 62 (prohibition of sale or supply, or importation,...
8In section 64(5) (protection for purchasers of medicinal products) for...
9(1) Section 67 (offences under Part III) is amended as...
10In section 72 (representative of pharmacist in case of death...
11In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...
12In section 87 (requirements as to containers)—
13In section 88(1) (distinctive colours, shapes and markings of medicinal...
14In section 91 (offences under Part V, and supplementary provisions)—...
15In section 104 (application of Act to certain articles and...
16In section 105 (application of Act to certain other substances...
17In section 107 (validity of decisions and proceedings relating thereto)—...
18(1) Section 108 (enforcement in England and Wales) is amended...
19In section 109 (enforcement in Scotland)— (a) in subsection (2)—...
20In section 110 (enforcement in Northern Ireland)—
21In section 111 (rights of entry)— (a) in subsection (1)...
22In section 113(1) (application of sampling procedure to substance or...
23In section 114(1) (supplementary provisions as to rights of entry...
24In section 121(4) (contravention due to default of other person),...
25In section 122(2) (warranty as defence), for the words “section...
26In section 123(1)(b) (offences in relation to warranties and certificates...
27In section 125 (prosecutions)— (a) in subsection (4)—
28In section 126 (presumptions)— (a) in subsection (1), omit paragraph...
29In section 128 (financial provisions)— (a) in subsection (1), for...
30In section 129 (orders and regulations)— (a) in subsection (2),...
31In section 130 (meaning of medicinal product and related expressions)—...
32In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...
33In section 132 (general interpretation provisions)— (a) for subsection (1)...
34In Schedule 3 (sampling)— (a) omit paragraphs 5 to 7;...
35In Schedule 4 (provisions relating to Northern Ireland)—
Medicines Act 1971
36(1) The Medicines Act 1971 shall have effect as follows....
PART 2Other primary legislation
Trade Descriptions Act 1968
37In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act...
House of Commons Disqualification Act 1975
38In Part II (bodies of which all members are disqualified)...
Northern Ireland Assembly Disqualification Act 1975
39In Part II (bodies of which all members are disqualified)...
Consumer Protection Act 1987
40Section 19(1) (interpretation of Part II) of the Consumer Protection...
Environmental Protection Act 1990
41In section 142(7) (powers to obtain information about potentially hazardous...
Value Added Tax Act 1994
42In Part II of Schedule 8 (zero-rating) to the Value...
Health Act 1999
43In section 60(2A)(c) (regulation of health care and associated professions)...
Communications Act 2003
44In section 368R(1) (interpretation of Part 4A) of the Communications...
Christmas Day and New Year’s Day Trading (Scotland) Act 2007
45In section 7 (interpretation) of the Christmas Day and New...
PART 3Northern Ireland Orders in Council
Health and Personal Social Services (Northern Ireland) Order 1972
46The Health and Personal Social Services (Northern Ireland) Order 1972...
Pharmacy (Northern Ireland) Order 1976
47In article 2(2) of the Pharmacy (Northern Ireland) Order 1976,...
Poisons (Northern Ireland) Order 1976
48In article 2(2) of the Pharmacy (Northern Ireland) Order 1976—...
Diseases of Animals (Northern Ireland) Order 1981
49In article 38 of the Diseases of Animals (Northern Ireland)...
Waste and Contaminated Land (Northern Ireland) Order 1997
50In article 33(6) of the Waste and Contaminated Land (Northern...
Shops (Sunday Trading &c.) (Northern Ireland) Order 1997
51In article 4(3) of the Shops (Sunday Trading &c.) (Northern...
PART 4The Medicines for Human Use (Clinical Trials) Regulations 2004
52The Medicines for Human Use (Clinical Trials) Regulations 2004 are...
53In regulation 2(1) (interpretation)— (a) before the definition “the Act”...
54In regulation 4(3) (responsibility for functions under the Directive) for...
55In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...
56In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...
57In regulation 47 (application of enforcement provisions of the Act)—...
58In regulation 48(5) (infringement notices) for “sections 108 to 110...
59In regulation 49(5) (offences) for “the Act” substitute “the 2012...
60In regulation 53(3) (construction of references to specified publications) for...
61In paragraph 4(2) of Schedule 5 (procedural provisions relating to...
62In Schedule 7 (standard provisions for manufacturing authorisations)—
63In paragraph 5(2) of Schedule 8 (procedural provisions relating to...
64For Schedule 9 substitute the following Schedule— SCHEDULE9 MODIFICATIONS OF...
PART 5Other United Kingdom, Scotland and Wales Secondary legislation
Medicines (Administration of Radioactive Substances) Regulations 1978
65In regulation 8(1) of the Medicines (Administration of Radioactive Substances)...
Importation of Animal Products and Poultry Products Order 1980
66In the Schedule to the Importation of Animal Products and...
Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986
67In rule 2 of The Medicines Act (Hearings by Persons...
Medicines Act (Hearings by Persons Appointed) Rules 1986
68In rule 2 of The Medicines Act (Hearings by Persons...
Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
69(1) The Medicines (Fixing of Fees Relating to Medicinal Products...
Medical Devices (Consultation Requirements) (Fees) Regulations 1995
70In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees)...
Prescription Only Medicines (Human Use) Order 1997
71(1) The Prescription Only Medicines (Human Use) Order 1997 is...
General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999
72In rule 7B(b) of the Schedule to the General Optical...
National Health Service (Charges for Drugs and Appliances) Regulations 2000
73The National Health Service (Charges for Drugs and Appliances) Regulations...
Biocidal Products Regulations 2001
74In Schedule 2 to the Biocidal Products Regulations 2001—
Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001
75In article 4(4) of the Medicines (Aristolochia and Mu Tong...
Misuse of Drugs Regulations 2001
76In regulation 2(1) of the Misuse of Drugs Regulations 2001—...
Medicines for Human Use (Kava-kava) (Prohibition Order) 2002
77In paragraph (d) of article 3 of the Medicines for...
Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
78In article 1(3) of the Medicines and Healthcare Products Regulatory...
Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003
79In the column “specified UK laws” of the Schedule to...
Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003
80In the Schedule to the Enterprise Act 2002 (Part 8...
Health Professions (Parts of and Entries in the Register) Order of Council 2003
81In article 6 of the Health Professions (Parts of and...
Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003
82(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform...
National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
83(1) The National Health Service (General Medical Services Contracts) (Scotland)...
National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004
84(1) The National Health Service (Primary Medical Services Section 17C...
National Health Service (General Medical Services Contracts) Regulations 2004
85(1) The National Health Service (General Medical Services Contracts) Regulations...
National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
86(1) The National Health Service (General Medical Services Contracts) (Wales)...
National Health Service (Personal Medical Services Agreements) Regulations 2004
87(1) The National Health Service (Personal Medical Services Agreements) Regulations...
National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004
88In Schedule 2 to the National Health Service (General Medical...
Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004
89(1) The Contracting Out (Functions relating to Broadcast Advertising) and...
General Optical Council (Registration Rules) Order of Council 2005
90In the Table in rule 10 of the Schedule to...
National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
91(1) The National Health Service (Free Prescriptions and Charges for...
Human Tissue (Quality and Safety for Human Application) Regulations 2007
92In regulation 2(3) of the Human Tissue (Quality and Safety...
Legislative and Regulatory Reform (Regulatory Functions) Order 2007
93(1) The Schedule to the Legislative and Regulatory Reform (Regulatory...
Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
94In paragraph (d) of article 3 of the Medicines for...
Specified Animal Pathogens Order 2008
95In article 5(2) of the Specified Animal Pathogens Order 2008—...
Specified Animal Pathogens (Wales) Order 2008
96In article 5(2) of the Specified Animal Pathogens (Wales) Order...
Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008
97In regulation 1(2) of the Health Service Branded Medicines (Control...
Specified Animal Pathogens (Scotland) Order 2009
98In article 5(2) of the Specified Animal Pathogens (Scotland) Order...
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
99(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009...
Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009
100(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland...
Single Use Carrier Bags Charge (Wales) Regulations 2010
101In Schedule 1(3) to the Single Use Carrier Bags Charge...
PART 6Northern Ireland statutory rules
Control of Pesticides Regulations (Northern Ireland) 1987
102For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern...
Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995
103In rule 4 of the Prison and Young Offenders Centre...
Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996
104In the Schedule to the Diseases of Animals (Importation of...
Pharmaceutical Services Regulations (Northern Ireland) 1997
105In Part 2 of Schedule 2 to the Pharmaceutical Services...
Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998
106In Schedule 1, Chapter 4, Section 4.8, Part C of...
Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998
107The Products of Animal Origin (Import and Export) Regulations (Northern...
Importation of Animal Pathogens Order (Northern Ireland) 1999
108In article 5(a) of the Importation of Animal Pathogens Order...
Biocidal Products Regulations (Northern Ireland) 2001
109In Schedule 2 to the Biocidal Products Regulations (Northern Ireland)...
Misuse of Drugs Regulations (Northern Ireland) 2002
110(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 are...
Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003
111In regulation 5(2)(c) of the Control of Substances Hazardous to...
Waste Management Licensing Regulations (Northern Ireland) 2003
112In paragraph 2 of Schedule 1 to the Waste Management...
Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004
113(1) The Health and Personal Social Services (General Medical Services...
Nursing Homes Regulations (Northern Ireland) 2005
114In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
Residential Care Homes Regulations (Northern Ireland) 2005
115In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
Children’s Homes Regulations (Northern Ireland) 2005
116In regulation 20(4)(b) of the Children’s Homes Regulations (Northern Ireland)...
Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006
117In regulation 3(1) of the Healthy Start Scheme and Day...
Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007
118In regulation 71(3)(a) of the Avian Influenza and Influenza of...
Day Care Setting Regulations (Northern Ireland) 2007
119In regulation 13(6)(b) of the Day Care Setting Regulations (Northern...
Residential Family Centres Regulations (Northern Ireland) 2007
120In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern...
Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007
121In regulation 3(1)(a) of the Natural Mineral Water, Spring Water...
Specified Animal Pathogens Order (Northern Ireland) 2008
122In article 5(2)(b) of the Specified Animal Pathogens Order (Northern...
Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009
123In regulation 2(2) of the Controlled Drugs (Supervision of Management...
Private Water Supplies Regulations (Northern Ireland) 2009
124In regulation 4(b) of the Private Water Supplies Regulations (Northern...
SCHEDULE 35Repeals and revocations

2012 No. 1916

Medicines

The Human Medicines Regulations 2012

Made

Laid before Parliament

Coming into force

The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 19721, having been designated for the purposes of section 2(2) of that Act in relation to medicinal products2 and to measures in the veterinary and phytosanitary fields for the protection of public health3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 19684, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.