- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (11/08/2021)
- Gwreiddiol (a wnaed Fel)
There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines (Products for Human Use) (Fees) Regulations 2016. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made by the team appear in the content and are referenced with annotations.
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PART 4 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
PART 9 Capital Fees for Inspections
31.Fees for inspections of pharmacovigilance service providers
32.Payer of inspection fee (contract laboratories and API manufacturing sites)
34.Fees for inspections relating to good clinical practice in clinical trials
35.Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
36.Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
37.Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
PART 10 Periodic Fees for Authorisations, Registrations and Licences
PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
SCHEDULES
PART 1 General: interpretation and categories of applications and variations
PART 2 Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates
PART 3 Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
PART 4 Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
PART 6 Capital Fee for the Renewal of a Marketing Authorisation
PART 6B Capital Fee for Testing of Samples by the Appropriate Authority
Waiver, reduction or refund of capital fees
4.Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
5.Withdrawal of application in relation to a certificate of registration
6.Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
7.Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
9.Surrender of marketing authorisation at same time as a variation application
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