The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993

Regulation 4(1)(a)

SCHEDULE 1 REQUIREMENTS OF APPLICANTS FOR PRODUCT LICENCES IN RESPECT OF VETERINARY MEDICINAL PRODUCTS OTHER THAN IMMUNOLOGICAL PRODUCTS

Interpretation

1.  References in this Schedule to requirements are those requirements set out in Title I of the Annex to Directive 81/852.

Requirements

2.  The applicant shall comply with the requirements set out in Part 1 (administrative data, summary of product characteristics, expert reports).

3.—(1) Subject to sub-paragraphs (2) and (3) below, the applicant shall comply with the requirements set out in Part 2 (analytical (physico-chemical, biological or microbiological) tests).

(2) Where at the request of the applicant a manufacturer of an active ingredient of the product submits details concerning the method of manufacture, quality control during manufacture and process validation directly to the licensing authority, the applicant shall obtain from the manufacturer—

(a) all the data necessary for him to take responsibility for the product,

(b) written confirmation that the manufacturer will ensure batch to batch consistency and inform the applicant before he modifies the manufacturing process or specifications, and

(c) written confirmation that the manufacturer will supply to the licensing authority all documents and particulars which may be required by the authority relating to any such modification,

and shall submit the data and confirmations received to the licensing authority.

(3) Where the applicant refers to a specification in a monograph in a pharmacopoeia but the licensing authority considers that such specification is insufficient to ensure the quality of the product, the applicant shall submit to the authority on request a more appropriate specification.

4.  The applicant shall comply with the requirements set out in Part 3 (safety and residues testing), and shall supply a copy of any certificate issued by a laboratory which carried out any such test certifying that the test was carried out in conformity with the principles of good laboratory practice as referred to in the second paragraph of Part 3.

5.—(1) Subject to sub-paragraph (2) below, the applicant shall comply with the requirements set out in Part 4 (pre-clinical and clinical testing).

(2) In the case of a trial of a product conducted in the United Kingdom, unless the trial is one under which the product is not to be identified, the labelling of any container and package of the product shall comply with the requirements contained in regulations relating to such product made under section 85(1) of the Act for the time being in force(1).

Regulation 4(1)(b)

SCHEDULE 2 REQUIREMENTS OF APPLICANTS FOR PRODUCT LICENCES IN RESPECT OF IMMUNOLOGICAL PRODUCTS

Interpretation

1.  References in this Schedule to requirements are those requirements set out in Title II of the Annex to Directive 81/852.

Requirements

2.  The applicant shall comply with the requirements set out in Part 5 (administrative data, summary of product characteristics, expert reports).

3.—(1) Subject to sub-paragraphs (2) and (3) below, the applicant shall comply with the requirements set out in Part 6 (analytical (physico-chemical, biological or microbiological) tests).

(2) Where at the request of the applicant a manufacturer of an active ingredient of the product submits details concerning the method of manufacture, quality control during manufacture and process validation directly to the licensing authority, the applicant shall obtain from the manufacturer—

(a) all the data necessary for him to take responsibility for the product,

(b) written confirmation that the manufacturer will ensure batch to batch consistency and inform the applicant before he modifies the manufacturing process or specifications, and

(c) written confirmation that the manufacturer will supply to the licensing authority all documents and particulars which may be required by the authority relating to any such modification,

and shall submit the data and confirmations received to the licensing authority.

(3) Where the applicant refers to a specification in a monograph in a pharmacopoeia but the licensing authority considers that such specification is insufficient to ensure the quality of the product, the applicant shall submit to the authority on request a more appropriate specification.

4.—(1) Subject to sub-paragraph (2) below, the applicant shall comply with the requirements set out in Parts 7, 8 and 9 (safety testing and efficacy trials), and shall supply a copy of any certificate issued by a laboratory which carried out a safety test certifying that the test was carried out in conformity with the principles of good laboratory practice as referred to in paragraph 3 of Section A of Part 7.

(2) In the case of an efficacy trial of a product conducted in the United Kingdom, unless the trial is one under which the product is not to be identified, the labelling of any container and package of the product shall comply with the requirements contained in regulations relating to such product made under section 85(1) of the Act for the time being in force(2).

Regulation 6

SCHEDULE 3

Regulations revoked	References	Extent of revocation
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971	S.I. 1971/973	The whole Regulations insofar as they relate to applications for product licences for veterinary medicinal products.
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Amendment Regulations 1972	S.I. 1972/1201	The whole Regulations insofar as they relate to applications for product licences for veterinary medicinal products.
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Amendment Regulations 1975	S.I. 1975/681	The whole Regulations insofar as they relate to applications for product licences for veterinary medicinal products.
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Amendment Regulations 1977	S.I. 1977/1051	The whole Regulations insofar as they relate to applications for product licences for veterinary medicinal products.
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Amendment Regulations 1983	S.I. 1983/1726	The whole Regulations insofar as they relate to applications for product licences for veterinary medicinal products.

(1)

The current Regulations are S.I. 1976/1726 (amended by S.I. 1977/996, 2168, 1981/1791, 1983/1729, 1985/2008 and 1989/1183) and S.I. 1988/1009.

(2)

The current Regulations are S.I. 1976/1726 (amended by S.I. 1977/996, 2168, 1981/1791, 1983/1729, 1985/2008 and 1989/1183) and S.I. 1988/1009.