PART 5Marketing authorisations

Consideration of application

Conditions of UK marketing authorisation F1or parallel import licence: general59.

(1)

F2Unless paragraph (1A) applies the licensing authority may—

(a)

grant a UK marketing authorisation subject to one or more of the conditions in paragraph (2); or

(b)

vary or remove a condition in paragraph (2) to which the UK marketing authorisation is subject.

F3(1A)

Where the application concerns a parallel import licence, the licensing authority may—

(a)

grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or

(b)

vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject.

(2)

Those conditions are—

(a)

to take certain measures for ensuring the safe use of the medicinal product and include them in the risk management plan;

(b)

to conduct post-authorisation safety studies;

(c)

to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Part 11;

(d)

any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(e)

the existence of an adequate pharmacovigilance system; and

(f)

to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.

(3)

F4In relation to a UKMA(NI) or F5UKMA(UK)(Category 2), an obligation to conduct such studies as are referred to in paragraph (2)(f) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive, while taking into account the scientific guidance referred to in Article 108a of the 2001 Directive.

F6(3A)

In relation to a UKMA(GB) F7or a UKMA(UK)(Category 1), an obligation to conduct such studies as are referred to in paragraph (2)(f) must—

(a)

be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive; and

(b)

take into account the scientific guidance that applies under regulation 205B in relation to post-authorisation efficacy studies.

(3B)

The Secretary of State may by regulations make provision F8... specifying the situations in which post-authorisation efficacy studies may be required F9in relation to a UKMA(GB) or UKMA(UK)(Category 1) by virtue of the condition referred to in paragraph (2)(f).

(3C)

Paragraph (3A)(a) ceases to apply on the coming into force of regulations made under paragraph (3B).

(4)

The F10UK marketing authorisation F11or parallel import licence must lay down deadlines for the fulfilment of the conditions in paragraph (2) F12where relevant and necessary.

F13(4A)

Where the application is one to which regulation 50A, 50E or 50F (applications to which paediatric-specific provisions apply) applies, the licensing authority must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a)

a risk management system be set up comprising a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions; or

(b)

specific post-marketing studies be performed and submitted for review.

(4B)

The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A (post-authorisation safety studies), a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4A).

(4C)

If the licensing authority grants a conditional marketing authorisation—

(a)

it must impose, as a condition of the conditional marketing authorisation, an obligation on the holder of the authorisation to complete ongoing studies, or to conduct new studies, with a view to confirming the that the positive therapeutic effects of the product outweigh the risks to the health of patients or the public associated with the product, and to provide the additional data referred to in regulation 50I(3)(a);

(b)

it may impose, as a condition of the conditional marketing authorisation, an obligation on the holder of that authorisation in relation to collection of pharmacovigilance data.

(4D)

If the licensing authority grants a UK marketing authorisation in relation to an advanced therapy medicinal product, it must, if it considers that there is a particular cause for concern, grant the UK marketing authorisation subject to a condition that—

(a)

a risk management system be set up which is designed to identify, characterise, prevent or minimise risks related to advanced therapy medicinal products, including an evaluation of the effectiveness of that system; or

(b)

that specific post-marketing studies be carried out and submitted for review by the licensing authority.

(4E)

The licensing authority may request the holder to submit, in addition to the assessment required to be submitted pursuant to Part 9 of Schedule 12A, a report assessing the effectiveness of any risk management system, and the results of any studies performed, in compliance with a condition imposed under paragraph (4D).

(5)

The licensing authority must notify the EMA of any F14UKMA(NI) or F15UKMA(UK)(Category 2) that it has granted subject to a condition included in accordance with this regulation.

(6)

The holder of the authorisation must incorporate any condition included in a marketing authorisation F16or parallel import licence in accordance with this regulation into the risk management system for the product.

(7)

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