Regulation 60 Conditions of UK marketing authorisation or parallel import licence: exceptional circumstancesF1

The licensing authority may—

The powers in paragraph (1) may be exercised only after consultation with the applicant for the authorisation F2or licence or (as the case may be) its holder.

The power in paragraph (1)(a) to grant an authorisation F3or licence subject to conditions may be exercised only—

The conditions must relate to a matter addressed by Annex I to the 2001 Directive.

The conditions may, in particular, relate to the safety of the product to which the authorisation or licence relates.

The conditions may, in particular, require that, where there is a serious adverse reaction relating to the use of the product—

The licensing authority must keep under review—

The licensing authority must consider those matters no less frequently than—

The licensing authority must notify the EMA of any UKMA(NI) or F5UKMA(UK)(Category 2) that it has granted subject to a condition included in accordance with this regulation.

The holder of the authorisation or licence must incorporate any condition included in a marketing authorisation F6or licence in accordance with this regulation into the risk management system for the product.

Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation or parallel import licence is subject.