- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
29.—(1) Unless paragraph (4) applies, where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a)in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or
(b)by more than one applicant for such an authorisation or licence,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, registration, authorisation, or licence.
(2) In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).
(3) Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a)in more than one manufacturer’s licence or manufacturing authorisation; or
(b)by more than one applicant for such a licence or authorisation,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.
(4) This regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
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.
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: