Paragraph 67 I1

For regulation 90 (omission of regulations 81 to 94 (offences relation to EU marketing authorisations) substitute—

“Application of regulations 81 to 94 (offences relating to EU marketing authorisations)

90

Before regulation 81 (obligation to update information supplied in connection with EU application), insert—

“Application of regulations 81 to 94

A81

Regulations 81 to 94 apply in relation to medicinal products for sale or supply in Northern Ireland.”.

Amendment of regulation 89 (offences in connection with withdrawal of product from market)

90A

In regulation 89(1)(b) (offences in connection with withdrawal of product from market) for “any of Articles 36, 37 and 38” substitute “ Article 37 or 38 ”.

Omission of regulation 91 (failure to notify results of third country clinical trials)

90B

Omit regulation 91.”.