Regulation 156 Article 126a authorisations

The licensing authority may grant an Article 126a authorisation for F1sale or supply of a medicinal product F2in Northern Ireland only, if the following conditions are met.

Condition A is that no United Kingdom marketing authorisation, certificate of registration or traditional herbal registration is in force F3in Northern Ireland for the product.

Condition B is that no application is pending in the United Kingdom for a marketing authorisation, certificate of registration or traditional herbal registration F4to be in force in Northern Ireland for the product.

Condition C is that the licensing authority considers that the placing of the product on the market in F5Northern Ireland is justified for public health reasons.

Condition D is that the product is imported from F6an EU member State that has, in accordance with the 2001 Directive, authorised the placing on the market of the product in that member State.

Condition E is that the person to whom the authorisation is granted is established in the European Union.

Before granting an Article 126a authorisation, the licensing authority must notify the authorisation holder in the member State mentioned in paragraph (5) of the proposal to grant the Article 126a authorisation.

Before granting an Article 126a authorisation, the licensing authority may request the competent authority in the member State mentioned in paragraph (5) to provide in accordance with Article 126a(3)(b) of the 2001 Directive a copy of—

An Article 126a authorisation remains in force for the period specified in it unless revoked before the end of that period.

That period may be specified by reference to the occurrence or non-occurrence of a particular event or events.