PART 11Pharmacovigilance

Transparency and communications

Obligations on licensing authority in relation to national medicines web-portal203.

(1)

The licensing authority must set up and maintain a national medicines web-portal (“the UK web-portal”) linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004 (“the EU web-portal”).

(2)

The licensing authority must make available publicly by means of the UK web-portal the following (at a minimum)—

(a)

the assessment reports prepared or revised by the licensing authority under regulation 64(5) and (6) (duties of licensing authority in connection with determination), each with a summary;

(b)

the summary of the product characteristics for the medicinal products concerned;

(c)

the package leaflet for the medicinal products concerned;

(d)

a summary of the risk management plan (if any) for the medicinal products concerned;

(e)

the list of medicinal products that are subject to additional monitoring referred to in Article 23 of Regulation (EC) No 726/2004; and

(f)

information on the different ways of reporting suspected adverse reactions to medicinal products to the licensing authority by patients or their carers, health care professionals, coroners or procurators fiscal (including by way of the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004).

Obligation on licensing authority in relation to public announcements204.

(1)

This regulation applies where the licensing authority intends to make a public announcement relating to information on pharmacovigilance concerns.

(2)

Subject to paragraph (4), the licensing authority must inform the bodies specified in paragraph (3) not less than 24 hours prior to making the public announcement.

(3)

The bodies specified in this paragraph are—

(a)

the EMA;

(b)

the European Commission; and

(c)

the competent authority of each EEA State other than the United Kingdom.

(4)

Paragraph (2) does not apply if the information in the announcement needs to be made public urgently for the protection of public health.

Obligations on holders in relation to public announcements205.

(1)

This regulation applies where the holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product.

(2)

The holder must inform the bodies listed in paragraph (3) of its intention to make the public announcement—

(a)

as soon as is practicable once it forms that intention; and

(b)

in any event no later than at the same time as, or before, the public announcement is made.

(3)

The bodies listed in this paragraph are—

(a)

the licensing authority;

(b)

the EMA; and

(c)

the European Commission.

(4)

The holder must ensure that the information in the public announcement—

(a)

is presented objectively; and

(b)

is not misleading.