Regulation 195 Obligation on licensing authority to assess PSURs ...F9

This regulation applies in the circumstances specified in paragraphs (1) and (1A).

This regulation applies where PSURs relating to a medicinal product F2authorised for sale or supply authorised under a UKMA(NI), F3UKMA(UK)(Category 2), THR(NI), THR(UK) or Article 126a authorisation have not been assessed under the EU single assessment procedure because—

This regulation applies where PSURs relating to a medicinal product authorised for sale or supply under a UKMA(GB) F7, UKMA(UK)(Category 1) or THR(GB) have been submitted to the licensing authority under regulations 191 to 192.

The licensing authority must assess the PSURs to determine whether there are any relevant changes.

Where the licensing authority has assessed a PSUR under paragraph (2) it must—

If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including—

In this regulation—

• “EU reference date” has the meaning given in regulation 193(6);

• “EU single assessment procedure” has the meaning given in regulation 194(5); and

• “relevant changes” in relation to a medicinal product means—

  1. (a)

     new risks,

  2. (b)

     risks that have changed, or

  3. (c)

     changes to the risk-benefit balance.