Regulation 68 Revocation, variation and suspension of UK marketing authorisation or parallel import licenceF20

The licensing authority may revoke, vary or suspend a UK marketing authorisation F1or parallel import licence if any of the following conditions is met.

Condition A is that the licensing authority thinks that—

Condition B is that the licensing authority thinks that the application or the material supplied with it is incorrect.

Condition C is that the licensing authority thinks that there has been a breach of—

Condition D is that the licensing authority thinks that a condition to which—

has not been fulfilled.

Condition E is that the licensing authority thinks that the holder of the authorisation has not complied with regulation 75(1) to (3) (requirements to provide information).

Condition F is that the holder of the authorisation F5or licence has ceased to be F6established in—

in accordance with the requirements of these Regulations.

Condition G is that—

Condition H is that—

Condition I is that the licensing authority thinks that urgent action to protect public health is necessary, in which case it—

Condition J is that—

Condition K is that the manufacture of the product to which the authorisation relates is not carried out in compliance with the particulars provided under paragraphs 5 and 9 of Schedule 8.

Condition L is that the licensing authority thinks that the term of the authorisation which specifies the way in which the product is to be made available, as described in regulation 62(1), is incorrect.

Condition M is that, in respect of a parallel import licence, the UK marketing authorisation in respect of the medicinal product that was specified in the application for that licence under paragraph 4 of Schedule 8A, has been varied, suspended or revoked by the licensing authority under this regulation.

Condition N is that, in respect of a parallel import licence, the licensing authority is no longer satisfied that the product is essentially similar to a product that has been granted a UK marketing authorisation.

The licensing authority may not exercise its powers under paragraph (1) by virtue of the condition in paragraph (11D)—

Condition O is that the licensing authority thinks that a variation of a UK marketing authorisation is necessary as a result of the submission of the results of a study by the holder of that authorisation under regulation 78A(14).

Condition P is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.

Condition Q is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(UK)(Category 1).

Condition R is that, in relation to a UKMA(UK)(Category 2), the licensing authority thinks that a variation is necessary in the interest of patients’ health in the United Kingdom so that the authorisation is treated as a UKMA(GB) and separate UKMA(NI).

Where Condition R is met, and the licence holder requests the cancellation of, or fails to renew, either the UKMA(GB) or UKMA(NI) that result from a variation being made under paragraph 11I, the licensing authority may revoke the corresponding UKMA(NI) or UKMA(GB) that results from that variation.

Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a UK marketing authorisation F17or parallel import licence, other than a proposal to vary an authorisation F18or licence on the application of its holder.

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