Answers to Query

Dear Jenna,

Thank you for the enquiry.

Yes, you have understood correctly the following:

• An import permit is required when importing a product, which does not have a marketing authorisation in any of the EEA member states.

• An import permit is not required when importing a product from another EEA member state, which has a marketing authorisation in another EEA member state (instead the medicines agency should be notified no later than 5 working days after the import).

UK is not part of EEA anymore, which means that import permit is required when importing unlicensed medicinal product from UK to Estonia, regardless whether it has a marketing authorisation in any EEA member state.

Please let me know it you have any further questions.

With best regards

Jaanika Reimaa

Specialist

Bureau of Import and Export Supervision

Department of Supervision

State Agency of Medicines

[email protected]

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

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Dear State Agency of Medicine,

I am contacting you as a Senior Regulatory Affairs Associate at Clinigen with an enquiry in relation to the import of medicinal products in to Estonia according to the Medicinal Products Act.

We understand that in order to import an unlicensed drug in to Estonia:

• An import permit is required where the product does not have a marketing authorisation in any of the EEA member states

• An import permit is not required where the product has a marketing authorisation in an EEA member state (instead the medicines agency should be notified no later than 5 working days after the import)

Please can you kindly clarify if an import permit is required when importing an unlicensed drug into Estonia, where the product is authorised in the UK (and supplied in UK commercial packaging):

1. In the case that there is a marketing authorisation for the same active substance/pharmaceutical form in an EEA member state

2. If there is not a marketing authorisation for the same active substance/pharmaceutical form in an EEA member state

The UK are no longer part of the EEA however our understanding is that wholesalers in Estonia may refer to EMA’s Article 57 database (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database) to determine if an import permit is required, and this database still includes products with a marketing authorisation in the UK.

Thank you in advance.
Kind regards,
Jenna