The Veterinary Medicines Regulations 2013

Regulation 5(2)

SCHEDULE 2U.K.The manufacture of veterinary medicinal products

PART 1U.K.Manufacturing authorisations

ApplicationU.K.

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

Time limitsU.K.

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.

Granting the authorisationU.K.

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 authorisationU.K.

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.

Suspension, variation or revocation of the authorisationU.K.

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.

Inspection of premisesE+W+S

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).

F1(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1(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 authorisationU.K.

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.

Qualified persons for manufactureU.K.

9.—(1) The Secretary of State may appoint as a qualified person (manufacture) any person 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;

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.

Refusal or revocation of appointmentU.K.

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 [F2another] country,F3..., the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested F4..., 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 [F5where the exporting country has demonstrated equivalent standards to those of the United Kingdom or ] where appropriate arrangements have been made F6...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 sitesU.K.

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.

PART 2U.K.Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccinesU.K.

14.—(1) The Secretary of State may authorise a person to manufacture autogenous vaccines and may authorise premises for the purpose of such manufacture by that person.

(2) In order to be authorised the premises must be under the supervision of—

(a)a veterinary surgeon; or

(b)a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.

(4) No person may manufacture an autogenous vaccine other than in accordance with an authorisation under sub-paragraph (1).

Types of authorisationU.K.

15.—(1) The authorisation must specify the products that may be manufactured.

(2) It may either be for the production of a single batch of product or for ongoing production of the products specified in the authorisation.

(3) If it is for a single batch it must be time limited.

(4) Only the products specified in the authorisation may be manufactured, and in the case of an authorisation for a single batch the product may only be manufactured before the expiry of the authorisation.

LabellingU.K.

16.  The operator of the premises must ensure that every container containing autogenous vaccine is labelled with—

(a)the name of the veterinary surgeon who ordered the vaccine;

(b)a precise description of the vaccine;

(c)the date the vaccine was produced;

(d)the name of the authorisation holder and address of the authorised premises;

(e)the expiry date;

(f)any necessary warnings; and

(g)instructions for use.

RecordsU.K.

17.  The operator of the premises must, as soon as is reasonably practicable, record—

(a)the name and address of the veterinary surgeon who ordered the vaccine;

(b)the identification of the source animal;

(c)the expiry date;

(d)the date of supply to the veterinary surgeon,

and must keep the records for at least five years.

Adverse reactionsU.K.

18.  The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine within 15 days of learning of the reaction.

Inspection of premisesU.K.

19.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

PART 3U.K.Authorisation of blood banks

Authorisation of blood banksU.K.

20.—(1) The Secretary of State may authorise blood banks for—

(a)the collection, storage and supply of blood, or

(b)the storage and supply of blood constituents obtained by the physical separation of donor blood into different fractions within a closed-bag system,

for the treatment of non-food-producing animals.

(2) The authorisation may be for either or both of these activities.

(3) In order to be authorised a blood bank must be under the supervision of—

(a)a veterinary surgeon named in the authorisation; or

(b)a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the blood bank.

(4) Before authorising a blood bank, the Secretary of State must be satisfied—

(a)that the welfare of animals used in the collection of blood will be respected; and

(b)that the production process will produce a consistent, safe product.

(5) The Secretary of State may suspend, vary or revoke an authorisation of a blood bank if—

(a)the holder no longer uses fit and proper processes;

(b)the premises in which the blood bank is being or is to be operated are not suitable;

(c)the equipment is not suitable; or

(d)the holder has not complied with these Regulations.

(6) Blood may only be collected under the responsibility of a veterinary surgeon.

(7) No person may operate a blood bank for treatment of animals other than in accordance with such an authorisation.

Supply and administration of blood from a blood bankU.K.

21.—(1) The operator of a blood bank may only supply blood to a veterinary surgeon.

(2) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer blood.

(3) No person may administer blood to a food-producing animal.

LabellingU.K.

22.—(1) The operator of a blood bank must ensure that every container used for the blood is labelled with—

(a)the identification of the donor animal;

(b)the date of collection;

(c)the authorisation number of the blood bank;

(d)any necessary warnings;

(e)the expiry date.

(2) There must be no specific therapeutic indication on the label or on any information relating to the product.

RecordsU.K.

23.  The operator of a blood bank must, as soon as is reasonably practicable, record—

(a)the date of collection;

(b)the identification of the donor animal;

(c)the veterinary surgeon who collected it;

(d)the expiry date;

(e)the date the blood was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied;

and must keep the records for at least five years.

Inspection of premisesU.K.

24.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

PART 4U.K.Authorisation of manufacturers of products for administration under the cascade

Authorisation to manufacture products for administration under the cascadeU.K.

25.—(1) The Secretary of State may authorise a person and premises to manufacture an unauthorised veterinary medicinal product for administration under the cascade.

(2) In order to be authorised the premises must be under the supervision of a person who the Secretary of State is satisfied has sufficient qualifications and experience to manufacture the product safely.

(3) Before authorising the premises, the Secretary of State must be satisfied that the production process will produce a safe product.

(4) The authorisation must specify what types of product it covers.

(5) No person may manufacture an unauthorised veterinary medicinal product other than in accordance with an authorisation under sub-paragraph (1).

LabellingU.K.

26.  The authorised person must ensure that, before a veterinary medicinal product is supplied, every container is labelled with—

(a)the name of the veterinary surgeon who ordered the veterinary medicinal product;

(b)a precise description of the veterinary medicinal product;

(c)the date of production;

(d)the name of the authorisation holder and the address of the authorised premises;

(e)the expiry date;

(f)any necessary warnings; and

(g)instructions for use.

RecordsU.K.

27.  The authorised person must, as soon as is reasonably practicable, record—

(a)the name and address of the veterinary surgeon who ordered the veterinary medicinal product;

(b)a precise description of the veterinary medicinal product;

(c)the date of production;

(d)the expiry date; and

(e)the date of supply to the veterinary surgeon,

and must keep the record for at least five years.

Adverse reactionsU.K.

28.  The authorised person must notify the Secretary of State of any adverse reactions to a product manufactured by that person within 15 days of learning of the reaction.

Inspection of premisesU.K.

29.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

PART 5U.K.Authorisation of equine stem cell centres

Authorisation of stem cell centresU.K.

30.—(1) The Secretary of State may authorise equine stem cell centres for the collection, storage, processing, production and administration of equine stem cells for use as an autologous treatment for horses.

(2) In order to be authorised a centre must be under the supervision of—

(a)a veterinary surgeon named in the authorisation; or

(b)a person named in the authorisation who the Secretary of State is satisfied is suitably qualified to operate the centre.

(3) Before authorising a centre, the Secretary of State must be satisfied—

(a)that the welfare of animals used in the collection of equine stem cells will be respected; and

(b)that the production process will produce a consistent, safe product.

(4) Equine stem cells may only be collected under the responsibility of a veterinary surgeon.

(5) The Secretary of State may suspend, vary or revoke an authorisation of an equine stem cell centre if—

(a)the holder no longer uses fit and proper processes;

(b)the premises in which the centre is being or is to be operated are not suitable;

(c)the equipment of the centre is not suitable; or

(d)the holder has not complied with these Regulations.

(6) No person may operate an equine stem cell centre other than in accordance with such an authorisation.

Supply and administration of stem cellsU.K.

31.—(1) The operator of an equine stem cell centre may only collect equine stem cells.

(2) The operator of an equine stem cell centre may not collect stem cells from embryonic tissues.

(3) No person other than a veterinary surgeon or someone acting under a veterinary surgeon’s responsibility may administer any product grown from collected equine stem cells.

(4) No person may administer any product grown from collected equine stem cells to a food-producing horse.

LabellingU.K.

32.—(1) The operator of an equine stem cell centre must ensure that every container used for the stem cell product is labelled with—

(a)the identification of the donor animal;

(b)the date of collection;

(c)the authorisation number of the equine stem cell centre;

(d)any necessary warnings;

(e)the expiry date.

(2) The operator of an equine stem cell centre must ensure that no specific therapeutic indication is included on the label or on any information relating to the product.

RecordsU.K.

33.  The operator of an equine stem cell centre must, as soon as is reasonably practicable, record for each stem cell product—

(a)the identification of the donor animal;

(b)the date of collection;

(c)the veterinary surgeon under whose responsibility the stem cells were collected;

(d)the expiry date;

(e)the date the product was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied,

and must keep the records for at least five years.

Inspection of premisesU.K.

34.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

OffencesU.K.

35.  It is an offence to fail to comply with—

(a)paragraph 4(3);

(b)paragraph 11;

(c)paragraph 14(4);

(d)paragraph 16;

(e)paragraph 17;

(f)paragraph 18;

(g)paragraph 20(6) or (7);

(h)paragraph 21;

(i)paragraph 22;

(j)paragraph 23;

(k)paragraph 25(5);

(l)paragraph 26;

(m)paragraph 27;

(n)paragraph 28;

(o)paragraph 30(4) or (6);

(p)paragraph 31;

(q)paragraph 32; or

(r)paragraph 33.