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: <…>…
