The Veterinary Medicines Regulations 2005

Regulation 5(2)

SCHEDULE 2 The manufacture of veterinary medicinal products

1. PART 1 Manufacturing authorisation

   1. 1. Application

   2. 2. Time limits

   3. 3. Granting the authorisation

   4. 4. The authorisation

   5. 5. Suspension or revocation of the authorisation

   6. 6. Representation to the Secretary of State

   7. 7. Inspection of premises

   8. 8. Report following inspection

   9. 9. Duties on the holder of a manufacturing authorisation

   10. 10. Qualified persons for manufacture

   11. 11. Refusal or revocation of appointment

   12. 12. Duties on a qualified person

   13. 13. Register

   14. 14. Test sites

2. PART 2 Authorisation of manufacturers of autogenous vaccines

   1. 15. Authorisation to manufacture autogenous vaccines

   2. 16. Types of authorisation

   3. 17. Labelling

   4. 18. Records

   5. 19. Adverse reactions

   6. 20. Inspection of premises

3. PART 3 Authorisation of blood banks

   1. 21. Authorisation of blood banks

   2. 22. Supply and administration of blood from a blood bank

   3. 23. Labelling

   4. 24. Records

   5. 25. Inspection of blood banks

PART 1 Manufacturing authorisation

Application

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

Time limits

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

(2) She shall process an application for a variation of a manufacturing authorisation within 30 days unless she notifies the applicant in writing that she is extending the time to 90 days.

Granting the authorisation

3.  The Secretary of State shall grant a manufacturing authorisation if she is satisfied that the applicant has at his disposal suitable and sufficient premises, staff, technical equipment and facilities for the manufacture, control and storage of the products, and will comply with his duties under these Regulations.

The authorisation

4.—(1) The manufacturing authorisation shall 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 name of the qualified person 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.

Suspension or revocation of the authorisation

5.—(1) The Secretary of State may suspend 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 his manufacturing authorisation;

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

(d) no longer has suitable premises or equipment.

(2) She may also suspend or revoke it if she is satisfied that the qualified person (manufacture) is not fulfilling his duties.

Representation to the Secretary of State

6.—(1) A person may make representations against a refusal, suspension or revocation of a manufacturing authorisation to a person appointed for the purpose by the Secretary of State.

(2) The appointed person shall consider the representations and report in writing to the Secretary of State.

(3) The Secretary of State shall give written notification of her final determination and the reasons for it.

Inspection of premises

7.—(1) The Secretary of State shall inspect the premises relating to a manufacturing authorisation on a regular basis to ensure compliance with good manufacturing practice.

(2) Within 90 days after an inspection, the Secretary of State shall issue a certificate of good manufacturing practice to the manufacturer if the inspection established that he is complying 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 shall issue a certificate of compliance with the monograph, if appropriate.

(4) The Secretary of State shall provide details of each certificate of good manufacturing practice that she issues 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, she shall provide details to the Agency for entry into the database.

Report following inspection

8.—(1) After each inspection of manufacturing premises, the inspector shall 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 shall inform the inspected manufacturer of the content of such reports.

Duties on the holder of a manufacturing authorisation

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

(2) He must have permanently at his 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.

(3) He must hold a current Certificate of Good Manufacturing Practice.

(4) He must have in place a system of Quality Assurance and Quality Control.

(5) He must 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.

(6) If he makes up a bulk package of veterinary medicinal products he 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.

(7) He 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 she requires it in writing.

Qualified persons for manufacture

10.—(1) The Secretary of State may appoint as a qualified person (manufacture) any person who is—

(a) registered as a pharmaceutical chemist with the Royal Pharmaceutical Society of Great Britain or with the Pharmaceutical Society of Northern Ireland; or

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

(c) a Chartered Biologist or a Fellow (or a Member or an Associate Member) of the Institute 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) if she is satisfied that he has the educational qualifications or practical experience to carry out the duties under this Schedule.

Refusal or revocation of appointment

11.—(1) The Secretary of State may refuse or revoke an appointment if she is not satisfied that a person has fulfilled or will fulfil his duties.

(2) A person may make representations against a refusal or revocation to a person appointed for the purpose by the Secretary of State, and the procedure in paragraph 6 shall apply.

Duties on a qualified person

12.—(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under his 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) The preceding paragraph shall not apply where appropriate arrangements have been made by the European Community 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.

(5) It is an offence to fail to comply with this paragraph.

Register

13.  The Secretary of State shall maintain and publish a register of holders of manufacturing authorisations and qualified persons (manufacture).

Test sites

14.—(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 2 Authorisation of manufacturers of autogenous vaccines

Authorisation to manufacture autogenous vaccines

15.—(1) The Secretary of State may authorise a person and premises to manufacture autogenous vaccines for administration in accordance with regulation 15.

(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 she authorises the premises, the Secretary of State must be satisfied that the production process will produce a consistent, safe product.

(4) Procedure for the suspension or revocation of the authorisation is the same as for the holder of a manufacturing authorisation.

(5) It is an offence to manufacture an autogenous vaccine other than in accordance with such an authorisation.

Types of authorisation

16.—(1) The authorisation shall specify the products that may be manufactured.

(2) It shall either be for the production of a single batch of product or for on-going production of the products specified in the authorisation.

(3) If it is for a single batch the authorisation shall 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.

Labelling

17.—(1) The operator 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;

(g) instructions for use, if any.

(2) It is an offence to fail to comply with this paragraph.

Records

18.—(1) The operator of premises manufacturing autogenous vaccines must, as soon as is reasonably practicable, record—

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

(b) the identity of the source animal;

(c) the expiry date;

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

(2) He must keep the records for at least five years.

(3) It is an offence to fail to comply with this paragraph.

Adverse reactions

19.  The authorised person must notify the Secretary of State of any adverse reactions to an autogenous vaccine of which he becomes aware within 15 days of learning of the reaction.

Inspection of premises

20.  The Secretary of State shall inspect the authorised premises every two years.

PART 3 Authorisation of blood banks

Authorisation of blood banks

21.—(1) The Secretary of State may authorise blood banks for the collection, storage and supply of blood for the treatment of non-food producing animals.

(2) 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.

(3) Before she authorises a blood bank, the Secretary of State must be satisfied —

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

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

(4) Procedure for the suspension or revocation of the authorisation shall be the same as for the holder of a manufacturing authorisation.

(5) Blood may only be collected under the supervision of a veterinary surgeon.

(6) It is an offence to operate a blood bank for treatment of animals other than in accordance with such an authorisation.

Supply and administration of blood from a blood bank

22.—(1) The blood may only be supplied to a veterinary surgeon.

(2) It may only be administered by a veterinary surgeon or under his supervision.

(3) It may only be administered to non-food producing animals.

(4) It is an offence to fail to comply with this paragraph.

Labelling

23.—(1) The operator must ensure that every container used for the blood is labelled with—

(a) the identity of the donor animal;

(b) the date of collection;

(c) the name of the veterinary surgeon who collected it;

(d) any necessary warnings;

(e) the expiry date.

(2) It is an offence to fail to comply with this paragraph.

Records

24.—(1) The operator of a blood bank must, as soon as is reasonably practicable, record—

(a) the date of collection;

(b) the identity 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.

(2) He must keep the records for at least five years.

(3) It is an offence to fail to comply with this paragraph.

Inspection of blood banks

25.  The Secretary of State shall inspect a blood bank every two years.

(1)

OJ No. L 228, 17.8.91, p. 70.