# The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2000, Regulation 4: Amendment of Schedule 3 to the principal Regulations


(1) After paragraph 1 of Schedule 3 to the principal Regulations (offences, penalties etc.) there shall be inserted the following paragraph—
“1A In respect of any product which is a relevant medicinal product, where, following a determination under regulation 3A(4) or (5), the licensing authority serve a notice in respect of that product on any person under regulation 3A(6) requiring him—
(a) to stop marketing the product from a date specified in the notice unless or until a marketing authorization is granted in respect of that product, if after the date specified—
(i) he places that product on the market, or
(ii) in the course of a business carried on by him, he sells, supplies to a member of the public or procures for sale or for supply to a member of the public that product,
without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence;
(b) not to place the product on the market unless or until a marketing authorization is granted in respect of that product, if he thereafter places the product on the market without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence.”.
(2) In paragraph 6(c) of Schedule 3 to the principal Regulations (offences, penalties etc.—obligations of holders of marketing authorizations), after the words “those Articles” there shall be added the words “or paragraph C.a of Part 2 of the Annex to Council Directive 75/318/EEC”.

---
Source: https://www.legislation.gov.uk/uksi/2000/292/regulation/4 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-amendment-regulations-2000/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.