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The Veterinary Medicines Regulations 2005
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Application for a variation
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12.—(1) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change) and the appropriate fee is payable for each application.
(2) The fee for an extension of a marketing authorisation as specified in Annex II to Commission Regulation (EC) No. 1084/2003 is the same as the fee for an application for a marketing authorisation for that product.
(3) If the variation is one specified in Annex I to Commission Regulation (EC) No. 1084/2003, the fee is £330 for a variation specified as Type 1A in that Annex.
(4) If the variation is specified as Type 1B in that Annex, the fee is £770 except in the following case—
Reductions to Type 1B fees
| Variation | Conditions | Fee |
|---|---|---|
| Identical changes to a number of products | All the products are from the same marketing authorisation holder | The fee for the first product is £770 and the fee for each subsequent product is £330 |
| Supporting data are identical | ||
| All applications are submitted at the same time |
(5) The fee for a variation classified as Type II in Article 3 of Commission Regulation (EC) No. 1084/2003 is £2,540 except in the following cases, where the fee is as specified:
Reductions to Type II fees
| Change | Conditions | Fee |
|---|---|---|
| a) Identical changes to a number of products. |
| The fee for the first product is £2540, and the fee for each subsequent product is £330 |
| b) Change of Distributor. | – No other aspect of the dossier is changed and the marketing authorisation holder remains the same. | £770 |
| c) Change of legal entity of marketing authorisation holder. | – No other aspect of the dossier is changed. | £770 |
| d) Simple dosage instruction changes intended to remove ambiguity. |
| £770 |
| e) Addition or change to safety warnings. |
| £770 |
| f) Corrections or simple text lay out changes to Summary of Product Characteristics and/or product literature. Included in this is the introduction of multilingual labelling. |
| £770 |
| g) Abbreviated resubmission of a previously refused Type II variation |
| £770 |
| h) Submission made following the formal advice of the Secretary of State |
| £770 |
| i) Approval of a mock-up for an authorised pack size. |
| £770 |
| j) Changes to the Summary of Product Characteristics and product literature of a Marketing Authorisation for Parallel Import as a direct consequence of the approval of a variation to the Summary of Product Characteristics and product literature for the UK authorised product. | – The only changes to the Summary of Product Characteristics and product literature are those required to bring the Marketing Authorisation for Parallel Import back in direct line with those of the UK authorised product. | £770 |
(1)
The Committee was established by Article 30 of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ No. L136, 30.4.2004, p. 1.
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