Application for a variation obtained under a national procedure
16.—(1) — This paragraph applies in relation to an application for a variation to a marketing authorisation obtained under a national procedure.
(2) 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.
(3) As an exception from sub-paragraph (1), an applicant who applies for more than one variation to the quality data in a marketing authorisation on the same application form may elect to pay a total fee of £4,620; but this sub-paragraph does not apply—
(a)if one or more of the variations relates to a new source of an active substance and the applicant does not submit a Certificate of Suitability issued by the European Pharmacopeia relating to the new source, or
(b)if a significant formulation change is applied for that requires a new assessment of the safety or efficacy of the veterinary medicinal product.
(4) If the variation is one specified as Type 1A in Commission Regulation (EC) No 1084/2003(1), the fee is £455.
(5) If the variation is specified as Type 1B in those Regulations, the fee is £885 except in accordance with the following table.
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 Supporting data are identical All applications are submitted at the same time | First product | 885 |
Each subsequent product | 455 | ||
(6) The fee for a variation classified as Type II in Commission Regulation (EC) No 1084/2003 is £2,310 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 | All the products are from the same marketing authorisation holder Supporting data are identical All applications are submitted at the same time | First product Each subsequent product | 2,310 455 |
| b) Change of distributor | No other aspect of the dossier is changed and the marketing authorisation holder remains the same | 885 | |
| c) Change of legal entity of marketing authorisation holder | No other aspect of the dossier is changed | 885 | |
| d) Simple dosage instruction changes intended to remove ambiguity | The change is not as a result of safety concerns No new studies are required to support the change The dosage regime remains the same | 885 | |
| e) Addition or change to safety warnings | No other aspects of the dossier are changed No safety warnings are removed No new studies are required to support the change and the proposed warnings serve to increase the protection of the user/ environment /target species as appropriate | 885 | |
| f) Corrections or simple text layout changes to summary of product characteristics and/or product literature. Included in this is the introduction of multilingual labelling | The changes are not a result of safety concerns No new studies are required to support the change and no other aspect of the dossier is changed The legibility of the current English labelling is not compromised The indications and warnings are the same in all languages | 885 | |
| g) Abbreviated resubmission of a previously refused Type II variation | At the time of refusal of a Type II variation, the Secretary of State has given written permission for resubmission under this category The application has been resubmitted within 3 months of the date the refusal advice was issued | 885 | |
| h) Submission made following the formal advice of the Secretary of State | The Secretary of State has already assessed the relevant data and formed an opinion on these The change is not required as a result of the holder failing to keep the Part II (quality) data in accord with current practice or in line with current guidelines issued by the Committee for Medicinal Products for Veterinary Use(2) | 885 | |
| i) Approval of a mock-up for an authorised pack size | The pack size is already authorised No new studies are required to support the change and no other aspect of the dossier is changed | 885 | |
| 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 United Kingdom 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 United Kingdom authorised product | 885 | |
k) Changes to details of the marketing authorisation holder’s pharmacovigilance system | No other changes to the dossier | 885 | |
On 1st January 2010 this Regulation is superseded by Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ No L 334, 12.12.2008, p. 7) but for the purposes of variations to marketing authorisations granted under the national procedure the classifications in Commission Regulation (EC) No 1084/2003 continue to be used.
The Committee was established by Article 30 of Regulation (EC) No 762/2004 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).