The Medicines (Products for Human Use-Fees) Regulations 2008

PART 9 Capital Fees for Inspections

Fees for inspections

27.—(1) Unless regulation 44 or 48 applies, a fee in accordance with paragraphs 1 to 7 of Schedule 2 is payable for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulations 24 or 30.

(2) Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of or applicant for, as the case may be, the authorization, registration, authorisation or licence in relation to which the inspection is made.

Payer of inspection fee (contract laboratories and API manufacturing sites)

28.  Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or, as the case may be, that API manufacturer.

Inspections in connection with multiple applications.

29.—(1) 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, authorisation, licence or registration.

(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) But this regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.

Fees for inspections relating to good clinical practice in clinical trials

30.  Unless regulation 44 applies a fee in accordance with paragraphs 2 and 3 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—

(a) is—

(i) conducting, or has conducted, a clinical trial, or

(ii) performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),

in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or

(b) has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.