- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
Regulation 51(1)
1. In this Schedule a reference to an application is to an application made by or on behalf of a small company.
2. In connection with a major application for a marketing authorisation for which the fee payable is that specified in entry 1(f) of the table in paragraph 24 of Part 2 of Schedule 2, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.
3. In connection with a complex application for a marketing authorisation, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—
(a)as to 50% at the time of the application; and
(b)as to 50% within 30 days following written notice from the licensing authority that the application has been determined.
4. In connection with an application to which paragraph 28 of Part 2 of Schedule 2 applies, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—
(a)as to 50% of the total payable in accordance with that paragraph at the time of the application; and
(b)as to 50% of that total within 30 days following written notice from the licensing authority that the application has been determined.
5. As regards the fee payable under regulation 17 in connection with an application—
(a)to which paragraph 36(2) of Part 3 of Schedule 2 applies—
(i)25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated; and
(ii)75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;
(b)to which paragraph 36(3), (4) or (5), of Part 3 of Schedule 2 applies—
(i)50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated, and
(ii)50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,
if the applicant so requests in writing.
6. In connection with an application for a traditional herbal registration, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.
7. In connection with a complex variation application or a new excipient variation application to vary a traditional herbal registration, the fee payable under regulation 19(1) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.
8. In connection with an application for a manufacturer’s licence, manufacturing authorisation, or a wholesale dealer’s licence, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.
9. In connection with an application for a marketing authorisation, traditional herbal registration, manufacturer’s licence or manufacturing authorisation, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 50(1)(b) and as to 50% within 12 months after that date.
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.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the 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: