[F1Manufacturing authorisationE+W+S

1.—(1) No person may carry out any activity mentioned in sub-paragraph (2) otherwise than in accordance with an authorisation granted under this Schedule (a “manufacturing authorisation”).

(2) For the purposes of sub-paragraph (1) the activities are—

(a)the manufacture of veterinary medicinal products (whether for use in Great Britain or another country);

(b)the carrying out of any part of the manufacturing process or of bringing a veterinary medicinal product to its final state, including the processing, assembling, packaging or repackaging, labelling or relabelling, storing, sterilising or releasing for supply of a veterinary medicinal product;

(c)the importation of any veterinary medicinal product for use in Great Britain.]

ApplicationN.I.

1.  An application for a manufacturing authorisation must be made to the Secretary of State.

[F2Application for authorisationE+W+S

2.—(1) An application for a manufacturing authorisation must be submitted to the Secretary of State electronically and must include the matters mentioned in sub-paragraph (2).

(2) For the purposes of sub-paragraph (1) the matters are—

(a)the name of the person who will hold the manufacturing authorisation and that person’s address or registered place of business;

(b)the names and addresses of the sites (including any site where work is undertaken on behalf of the proposed holder under contract) where—

(i)each stage of the manufacturing process or of bringing a veterinary medicinal product to its final state, including processing, assembling, packaging or repackaging, labelling or relabelling, storing or sterilising, is carried out;

(ii)any imported products are held; or

(iii)any control or batch release is carried out;

(c)a description of the veterinary medicinal products or pharmaceutical forms proposed to be manufactured or imported under the authorisation;

(d)the name of the proposed qualified person (manufacture) for the purposes of paragraph 9;

(e)the name of the person proposed to have responsibility for quality control;

(f)the qualifications and a description of the relevant experience of the person proposed to have responsibility for quality control;

(g)the name of the person proposed to have responsibility for production;

(h)the qualifications and a description of the relevant experience of the person proposed to have responsibility for production;

(i)a declaration that the applicant complies with good manufacturing practice and any relevant legislation; and

(j)a declaration that any site mentioned in paragraph (b) is ready for inspection.]

Time limitsN.I.

2.—(1) The Secretary of State must process an application for a manufacturing authorisation within 90 days of receiving it.

(2) The Secretary of State must process an application for a variation of a manufacturing authorisation within 30 days unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

[F3Procedure for grant of authorisations and time limitsE+W+S

3.—(1) The Secretary of State must process an application mentioned in paragraph 2 within 90 days of validating the application.

(2) The Secretary of State must inspect the sites mentioned in paragraph 2(2)(b) within 90 days of validating the application.

(3) The Secretary of State must grant the manufacturing authorisation if satisfied, following the inspection mentioned in sub-paragraph (2), that—

(a)the sites are suitable for the intended purposes;

(b)the applicant has—

(i)suitable and sufficient staff, technical equipment and facilities for the proposed activities; and

(ii)a documented quality management system in place.

(4) Where the Secretary of State is not satisfied in relation to one or more of the matters mentioned in sub-paragraph (3), the Secretary of State may—

(a)reject the application; or

(b)grant a conditional manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(5) The Secretary of State may extend the period for which a conditional manufacturing authorisation is granted under sub-paragraph (4)(b).

(6) Where a conditional manufacturing authorisation is granted under sub-paragraph (4)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect without those conditions.]

Granting the authorisationN.I.

3.  The Secretary of State must grant a manufacturing authorisation on being satisfied that the applicant has suitable and sufficient premises, staff, technical equipment and facilities for the manufacture, control and storage of the products, and will comply with these Regulations.

The authorisationE+W+S

4.—(1) The manufacturing authorisation must specify—

(a)the types of veterinary medicinal products and pharmaceutical forms that may be manufactured [F4, controlled] or imported;

[F5(b)the name and address of the site where the products are to be manufactured or controlled, or to which they are to be imported;]

(c)the name and address of the person holding the authorisation;

(d)the address of the premises to which it relates;

(e)the names of all qualified persons nominated to act under this Schedule.

(2) It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3) The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used.

The authorisationN.I.

4.—(1) The manufacturing authorisation must specify—

(a)the types of veterinary medicinal products and pharmaceutical forms that may be manufactured or imported;

(b)the place where they are to be manufactured or controlled;

(c)the name and address of the person holding the authorisation;

(d)the address of the premises to which it relates;

(e)the names of all qualified persons nominated to act under this Schedule.

(2) It may specify that different activities must be carried out in different premises or parts of premises, and may require the holder of the manufacturing authorisation to restrict access to premises or parts of premises to persons carrying out activities there.

(3) The holder of a manufacturing authorisation must notify the Secretary of State, and if necessary apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used.

[F6Application for variation to the authorisationE+W+S

4A.—(1) The holder of a manufacturing authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before—

(a)making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used;

(b)changing the qualified person (manufacture), the person with responsibility for quality control or the person with responsibility for production.

(2) The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

(3) The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 3(3) as regards the proposed variation.

(4) The Secretary of State may inspect any site to which the manufacturing authorisation or proposed variation relates in connection with the application.

(5) Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may—

(a)reject the application; or

(b)grant a conditional variation to the manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

(6) The Secretary of State may extend the period for which a conditional variation to the marketing authorisation is granted under sub-paragraph (5)(b).

(7) Where a conditional variation to the manufacturing authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.]

[F7Suspension, revocation etc] of the authorisationE+W+S

5.—(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a)has not complied with these Regulations;

(b)has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c)has produced a veterinary medicinal product outside the terms of a marketing authorisation; F8...

(d)no longer has suitable premises or equipment.

[F9(e)has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f)has not paid any fee required under these Regulations]

[F10(2) The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3) In particular, the Secretary of State may—

(a)suspend the manufacture or import of veterinary medicinal products;

(b)suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c)suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.]

Suspension, variation or revocation of the authorisationN.I.

5.—(1) The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a)has not complied with these Regulations;

(b)has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c)has produced a veterinary medicinal product outside the terms of a marketing authorisation; or

(d)no longer has suitable premises or equipment.

(2) The Secretary of State may also suspend, vary or revoke it on being satisfied that the qualified person (manufacture) is not fulfilling their duties under these Regulations.

[F11Good manufacturing practice certificates and inspection of sites]E+W+S

6.—(1) The Secretary of State must, from time to time, inspect [F12sites] [F13authorised] under paragraph 3, basing the frequency of the inspection on the risks associated with each [F14site’s history] and the nature of the products handled at the [F12sites].

[F15(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection establishes that the manufacturer has complied with the requirements of these Regulations in respect of the site to which the inspection relates.

(2A) Where the Secretary of State does not consider that compliance is established after inspection in accordance with sub-paragraph (2), the Secretary of State must enter that fact in the register mentioned in paragraph 12(a).

(2B) The Secretary of State may carry out an inspection on a site occupied by a manufacturer established in a country other than the United Kingdom notwithstanding any arrangements that may have been entered into between the United Kingdom and that country.

(2C) The importer of a veterinary medicinal product must ensure before importation that the manufacturer of that product has—

(a)a valid certificate of good manufacturing practice issued by the Secretary of State; or

(b)an equivalent certificate issued by a regulatory authority—

(i)with which the Secretary of State has an agreement or arrangement for such purposes; or

(ii)which the Secretary of State considers to have demonstrated equivalent standards to those in the United Kingdom.]

F16(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inspection of premisesN.I.

6.—(1) The Secretary of State must, from time to time, inspect premises registered under paragraph 3, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(2) Within 90 days after an inspection, the Secretary of State must issue a certificate of good manufacturing practice to the manufacturer if the inspection established compliance with the principles and guidelines on good manufacturing practice in accordance with Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products(1).

(3) If an inspection is carried out at the request of the European Pharmacopoeia to establish compliance with a monograph, the Secretary of State must issue a certificate of compliance with the monograph, if appropriate.

(4) The Secretary of State must provide details of each certificate of good manufacturing practice issued to the Agency for entry into a database.

(5) If the outcome of the inspection is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice, the Secretary of State must provide details to the Agency for entry into the database.

Report following inspectionU.K.

7.—(1) After each inspection of manufacturing premises, the inspector must make a written report to the Secretary of State on whether the principles and guidelines on good manufacturing practice and the conditions of these Regulations are being complied with.

(2) The Secretary of State must inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisationE+W+S

8.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.

[F17(2) The holder must have permanently at the holder’s disposal the services of—

(a)staff complying with any legal requirements in relation to manufacture of veterinary medicinal products; and

(b)at least one qualified person (manufacture).

(2A) The holder must place at the disposal of any qualified person (manufacture) all necessary documents, premises and technical and other facilities in order to enable that person to discharge their duties as the qualified person.

(2B) Where any qualified person (manufacture) ceases to be available to provide services to the holder, the holder must give notice of the fact to the Secretary of State—

(a)at least 30 days in advance of the person’s ceasing to be so available; or

(b)where such notice is not possible, at the earliest opportunity.]

[F18(3) The holder must—

(a)comply with good manufacturing practice and have a valid certificate of good manufacturing practice;

(b)use as starting materials only active substances which have been manufactured in accordance with good manufacturing practice and distributed in accordance with good distribution practice for active substances;

(c)verify that each manufacturer, distributor or importer from whom the holder obtains active substances and to which paragraph 26 applies is registered with the Secretary of State under that paragraph;

(d)carry out audits based on a risk assessment in relation to the manufacturers, distributors and importers from which the holder obtains active substances;

(e)have in place a system of quality assurance and quality control; and

(f)give to the Secretary of State, on request, proof of any control test specified by the Secretary of State which has been carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.

(3A) The holder of a manufacturing authorisation must inform the Secretary of State and the holder of any relevant marketing authorisation where the holder obtains information that veterinary medicinal products which fall within the scope of its manufacturing authorisation are falsified, or are suspected of being falsified, irrespective of whether those products were distributed within the legal supply chain or by illegal means.]

(4) A holder who makes up a bulk package of veterinary medicinal products must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—

(a)the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;

(b)the batch number;

(c)the expiry date;

(d)any storage requirements; and

(e)any other warning necessary for the safe handling of the package.

(5) A holder must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if required in writing to do so.

[F19(6) A holder must keep detailed records of all veterinary medicinal products which the holder supplies.]

Duties on the holder of a manufacturing authorisationN.I.

8.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with the marketing authorisation.

(2) The holder must have permanently at their disposal the services of at least one qualified person (manufacture) who is on the register of qualified persons (manufacture) maintained by the Secretary of State and must place all necessary facilities at the qualified person’s disposal.

(3) The holder must—

(a)have a current Certificate of Good Manufacturing Practice;

(b)have in place a system of Quality Assurance and Quality Control; and

(c)give to the Secretary of State on request proof of all control tests carried out on the veterinary medicinal product or the constituents and intermediate products of the manufacturing process in accordance with the data submitted in support of the application for the marketing authorisation.

(4) A holder who makes up a bulk package of veterinary medicinal products must ensure that the package is labelled, in a way that the label is clearly visible and legible, with—

(a)the name of the veterinary medicinal product, its strength as shown in the summary of product characteristics and its pharmaceutical form;

(b)the batch number;

(c)the expiry date;

(d)any storage requirements; and

(e)any other warning necessary for the safe handling of the package.

(5) A holder must keep an adequate number of representative samples of each batch of a veterinary medicinal product in stock at least until the expiry date of the batch, and must submit any such sample to the Secretary of State if required in writing to do so.

[F20Good manufacturing practiceE+W+S

8A.—(1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with this paragraph, whether the manufacturing is performed by the holder or another person.

(2) The manufacturing operations must be conducted in accordance with a written methodology, to be known as the “pharmaceutical quality system” or “PQS”.

(3) The PQS must be—

(a)clear;

(b)systematically reviewed from time to time in the light of experience; and

(c)capable of consistently manufacturing veterinary medicinal products which are of the required quality and which meet the requirements of the relevant marketing authorisation.

(4) The critical steps of the manufacturing process set out in the PQS must be validated.

(5) Any significant amendments to the PQS must be validated.

(6) The PQS must provide for—

(a)appropriately qualified and trained personnel;

(b)adequate premises and space;

(c)suitable equipment and access to services;

(d)suitable materials, containers and labelling;

(e)relevant procedures and instructions;

(f)suitable storage and transport;

(g)investigation into complaints and defects.

(7) The PQS must provide for any significant deviations from its provisions to be—

(a)fully recorded, and

(b)investigated, with appropriate corrective and preventative action implemented.

(8) The holder of a manufacturing authorisation must ensure that records of the manufacturing process, including distribution, are kept in a comprehensible and accessible form until the later of—

(a)the date which is five years after the date on which the veterinary medicinal product is placed on the market;

(b)the date which is one year after the expiry date of the batch of veterinary medicinal product.

(9) In this paragraph, a process (or part of a process) is “validated” if scientific evidence is assembled which demonstrates that it is capable of consistently delivering expected results.]

[F20Recalled and counterfeit productsE+W+S

8B.—(1) The holder of a manufacturing authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation.

(2) The holder of a manufacturing authorisation must record any veterinary medicinal product which is—

(a)recalled (whether or not the holder physically receives the recalled product); or

(b)discovered to be counterfeit.

(3) Where any veterinary medicinal product is recalled and physically received, the qualified person (manufacture) must assess the recalled product in order to determine whether—

(a)the product has been stored (including during transport) in accordance with the summary of product characteristics;

(b)the product is a genuine product and not counterfeit.

(4) Where the qualified person (manufacture) determines that a recalled veterinary medicinal product does not satisfy sub-paragraph (3)(a) or (b), or where it is not possible for the qualified person (manufacture) to determine whether the product does so, the product may not be re-sold.

(5) The qualified person (manufacture) must record any assessment and determination made under sub-paragraphs (3) and (4).

(6) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a manufacturing authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph.

(7) The holder of a manufacturing authorisation must keep any information recorded under this paragraph for five years.]

Qualified persons for manufactureU.K.

9.—(1) The Secretary of State may appoint as a qualified person (manufacture) any person [F21(including the manufacturer of a veterinary medicinal product)] who is—

(a)a member of the Royal Pharmaceutical Society or registered with the Pharmaceutical Society of Northern Ireland;

(b)a Chartered Chemist or a Fellow, Member or Associate Member of the Royal Society of Chemistry; or

(c)a Chartered Biologist or a Fellow, Member or Associate Member of the Society of Biology;

[F22(1A) For the purposes of sub-paragraph (1), a person has sufficient practical experience if they have been engaged in one or more of the activities mentioned in sub-paragraph (1B) for at least two years in the provision of services to the holder of a manufacturing authorisation.

(1B) For the purposes of sub-paragraph (1A) the activities are—

(a)quality assurance of medicinal products;

(b)qualitative analysis of medicinal products;

(c)quantitative analysis of active substances.

(1C) The Secretary of State may treat the reference in sub-paragraph (1A) to two years of practical experience as a reference to—

(a)one year, where the person’s formal course of study lasted for at least five years;

(b)six months, where the person’s formal course of study lasted for at least six years.]

who qualified on the basis of a formal course of study lasting not less than three years full-time or equivalent and who has sufficient practical experience to carry out the duties under this Schedule.

(2) The Secretary of State may exceptionally appoint a person who is not a member of one of those institutions to act as a qualified person (manufacture) on being satisfied that that person has the educational qualifications or practical experience to carry out the duties under this Schedule.

[F23Refusal, revocation, suspension or variation of appointment]E+W+S

10.  The Secretary of State may refuse [F24, revoke, suspend or vary] an appointment if the Secretary of State is not satisfied that a person has fulfilled or will fulfil duties under these Regulations.

Refusal or revocation of appointmentN.I.

10.  The Secretary of State may refuse or revoke an appointment if the Secretary of State is not satisfied that a person has fulfilled or will fulfil duties under these Regulations.

Duties on a qualified personE+W+S

11.—(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.

(2) If a manufacturer imports a veterinary medicinal product from [F25another] country,F26..., the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested F27..., including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.

(3) Sub-paragraph (2) does not apply [F28where the exporting country has demonstrated equivalent standards to those of the United Kingdom or ] where appropriate arrangements have been made F29...with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph (2) have been carried out in the exporting country.

(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

Duties on a qualified personN.I.

11.—(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.

(2) If a manufacturer imports a veterinary medicinal product from a third country, including a product manufactured in a member State, the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested in a member State, including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.

(3) Sub-paragraph (2) does not apply where appropriate arrangements have been made by the European Union with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph (2) have been carried out in the exporting country.

(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

RegisterU.K.

12.  The Secretary of State must maintain and publish a register of—

(a)holders of manufacturing authorisations; and

(b)qualified persons (manufacture) appointed under paragraph 9(2).

Test sitesE+W+S

13.—(1) The Secretary of State may authorise [F30a site] to act as a test site to carry out contract testing for a holder of a manufacturing authorisation.

(2) The [F31site] must have a current certificate of good manufacturing practice.

[F32(2A) The site must be specified in an existing manufacturing authorisation.]

(3) [F33Inspection of the site is] the same as for a manufacturing authorisation.

Test sitesN.I.

13.—(1) The Secretary of State may authorise premises to act as a test site to carry out contract testing for a holder of a manufacturing authorisation.

(2) The premises must have a current certificate of good manufacturing practice.

(3) Authorisation and inspection of the premises are the same as for a manufacturing authorisation.