- Latest available (Revised)
- Point in Time (18/12/2003)
- Original (As made)
Version Superseded: 17/11/2004
Point in time view as at 18/12/2003. This version of this provision has been superseded.
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
There are currently no known outstanding effects for the The Medicines (Products for Animal Use—Fees) (Amendment) Regulations 2003 (revoked), Section 2.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
2.—(1) Regulations 2, 3, 12 to 17 and 19 of the principal Regulations shall be amended as specified in this regulation.
(2) In regulation 2 (Interpretation)—
(a)paragraph (1) shall be amended in accordance with Schedule 1 to these Regulations.
(b)for paragraph (2) substitute:
“(2) Other expressions used in these Regulations have the same meaning as in the Act and the 1971 Act, and, in the case of variations to marketing authorisations other than mutually recognised marketing authorisations, as in Directive 851/81/EEC M1 and Regulation (EC) No 541/95, M2 but in all other cases, as in Directive 2001/82/EC M3 and Regulation (EC) No 1084/2003 M4.”.
(3) For regulation 3, substitute:
3.—(1) Where a person applies for the grant of a marketing authorisation, a product licence, a manufacturer’s licence, a wholesale dealer’s licence, an animal test certificate or an export certificate, he shall pay the relevant fee prescribed in Part II of Schedule 1.
(2) Where a person requests from the licensing authority a certified copy of an export certificate which he has been or is to be granted, he shall pay the fee prescribed in Part II of Schedule 1, paragraph 10.
(3) Paragraph (1) shall not be taken to impose any obligation on an applicant for a new marketing authorisation or product licence falling within regulation 11(2) or on an applicant for a variation with extras.
3A. Where the holder of a marketing authorisation (other than a mutually recognised marketing authorisation) or of an animal test certificate requests the licensing authority to undertake specific batch control in respect of a batch of a veterinary medicinal product, he shall pay a fee of £475.”
(4) In regulation 12 (manufacturer’s licences: annual fees), for “an annual fee of £215”, substitute “ an annual fee of £220 ”.
(5) In regulation 13 (wholesale dealer’s licences: annual fees),
(a)in paragraph (1), for “£430”, substitute “ £445 ”; and
(b)in paragraph (2), for “£215”, substitute “ £220 ”.
(6) In regulation 14 (registration of homoeopathic veterinary medicinal products),
(a)in paragraph (2), for “£80”, substitute “ £85 ”; and
(b)in paragraph (3), for “£95”, substitute “ £100 ”.
(7) In regulation 15 (marketing authorisations, product licences and animal test certificates: fees for references to the Veterinary Products Committee or to the Medicines Commission),
(a)in paragraph (a), after “renewal of an animal test certificate”, delete “or” ,
(b)in paragraph (b) after “renewal of a marketing authorisation,”, insert “ or ”, and
(c)insert a new paragraph as follows:
“(c)in relation to an application for a variation with extras insofar as it falls within regulation 9 of the 1994 Regulations,”.
(8) Regulation 16 (payment of fees) shall be amended as follows:
(a)in paragraph (1) for “the Minister of Agriculture, Fisheries and Food”, substitute “ the Secretary of State for Environment, Food and Rural Affairs ”;
(b)in paragraph (2) delete “or the Minister of Agriculture, Fisheries and Food as may be indicated on the written notice requiring payment referred to in regulation 17(2)”.
(9) In regulation 17 (time for payment of fees)—
(a)in paragraph (4)—
(i)for “Regulation (EC) No 541/95,” substitute “ Regulation (EC) 1084/2003 ”;
(ii)for “a marketing authorisation, or” substitute “ a marketing authorisation, animal test certificate, export certificate or request for a certified copy of an export certificate, or ”; and
(iii)for “Directive 81/851/EEC” substitute “ Directive 2001/82/EC ”.
(b)after paragraph (5), insert:
“(5A) the licensing authority need not undertake specific batch control if the person who requests it has not paid or caused to be paid the fee required under these Regulations.
(5B) Nothing in paragraph (5A) shall be construed as preventing the licensing authority from fulfilling its obligations to observe the duties imposed on member States under Articles 81 or 83 of Directive 2001/82/EC.”.
(10) In regulation 19(2), for “Directive 81/851/EEC” substitute “ Directive 2001/82/EC ”.
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.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
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: