Europe – Member states contact points for translations review

The e-mail should include at least the following information:

E-mail subject: Post-opinion review – Day <…> – <Product name> – <EMEA procdure number>

Deadline for comments: <…>

E-mail text: Please find attached the product information for <Product name>  in your national language.

<For PSUR: Period covered by the PSUR: <dd.mm.yyyy> – <dd.mm.yyyy>

Please note that due to the existence of usage patent(s) the Annexes reflect differences in SmPC/PL compared to the reference medicinal product> [only for generics/ hybrids/ biosimilars – delete if not applicable]

Comments in Word must be sent directly to < MAH translation contact point e-mail >  with copy to the Agency <Product Shared Mailbox>.

Deadline for the linguistic review is: <…>…