Brussels, 27.4.2023

COM(2023) 222 final

ANNEX

to the

Proposal for a Regulation of the European Parliament and of the Council

on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013

{SEC(2023) 172 final} - {SWD(2023) 117 final} - {SWD(2023) 118 final} - {SWD(2023) 119 final}


ANNEX II

Standard form for notification pursuant to Article 5(3), points (b) and (c).

Tick the appropriate box

□ New notification

□ Update of an existing notification

(a)Name and address of the maker

…

(b)Purpose of making

□ Export

□ Storing

□ Export and storing

(c)Member State in which making is to take place and Member State in which first related act (if any) prior to making is to take place

Member State of making

(d)

(Member State of first related act (if any))

(e)Number of unitary certificate having effect in the Member State of making and number of certificate granted in Member State of first related act (if any) prior to making

Unitary certificate having effect in the Member State of making

(Certificate of Member State of first related act (if any))

(f)For medicinal products to be exported to third countries, reference number of marketing authorisation, or the equivalent of such authorisation, in each third country of export

(g)

(h)