- Draft legislation
This is a draft item of legislation and has not yet been made as a UK Statutory Instrument. This draft has been replaced by a new draft, No. 788
Regulation 4(4)
1. In this Schedule—
“converted EU marketing authorisation” means an EU marketing authorisation to which paragraph 2 applies;
“EU marketing authorisation” means a marketing authorisation for a veterinary medicinal product granted by the European Commission in accordance with Title 3 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(1).
2. This paragraph applies to an EU marketing authorisation which—
(a)was granted before exit day, and
(b)remains in force immediately before exit day.
3. A converted EU marketing authorisation has effect on and after exit day for the purposes of these regulations as if it were a marketing authorisation granted by the Secretary of State under these Regulations on the date it was originally granted—
(a)on the terms which were in force immediately before exit day,
(b)with the benefit of any periods of data marketing exclusivity from which the holder benefited immediately before exit day, and
(c)subject to any suspension or post-authorisation obligations which were in force immediately before exit day.
4. Without prejudice to the generality of paragraph 3—
(a)the holder of a converted EU marketing authorisation is subject to the annual fee as set out in paragraph 26 of Schedule 7;
(b)a converted EU marketing authorisation is to be treated as having been granted in accordance with regulation 4(3) and Schedule 1 for the purposes of Regulation (EC) No 469/2009.”
OJ No L 136, 30.4.2004, p 1, as last amended by Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p 38).
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Draft Explanatory Memorandum sets out a brief statement of the purpose of a Draft Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Draft Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: