Subject: Ed: Medicinal Products Act / Import authorisation query (unlicensed medicines)
From: "Jaanika Reimaa" <[email-masked]>
To: Kärolin Jenas <[email-masked]>
Date: Mon, 15 Jul 2024 13:12:03 +0300

Saatja: Eriluba
Saatmisaeg: neljapäev, 25. jaanuar 2024 16:48
Adressaat: 'Jenna Bruce' <[email-masked] 
<mailto:[email-masked]> >
Teema: Vs: Medicinal Products Act / Import authorisation query (unlicensed 
medicines)

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
 <mailto:[email-masked]> [email-masked]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
 <http://www.ravimiamet.ee/> www.ravimiamet.ee

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Saatja: Jenna Bruce <[email-masked] 
<mailto:[email-masked]> >
Saatmisaeg: kolmapäev, 24. jaanuar 2024 16:18
Adressaat: Ravimiamet <[email-masked] <mailto:[email-masked]> >; 
Eriluba <[email-masked] <mailto:[email-masked]> >
Koopia: Clinigen Regulatory Affairs <[email-masked] 
<mailto:[email-masked]> >
Teema: Medicinal Products Act / Import authorisation query (unlicensed 
medicines)

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

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

Jenna Bruce
Regulatory Affairs Associate

t: +44 1932 824000

m: +44 7880 201227

e: [email-masked] <mailto:[email-masked]>

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