Küsimused

Dear Carmen,

Thank you for your enquiry.

We, as the competent authority for medical devices in Estonia, issue Free Sale Certificates to Estonian manufacturers or authorised representatives for medical devices and in vitro diagnostic medical devices for the purpose of export.

The highest authority in our organisation to issue (sign) Free Sale Certificates is our Director General, but these rights have also been granted to the Head of the Department of Medical Devices and a specialist in the Department of Medical Devices.

For Medicines, Estonian State Agency of Medicines participates in the WHO Certification Scheme and, upon request, will issue a Certificate of Pharmaceutical Product (CPP) for medicinal products that are authorised and manufactured within the country.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk
Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Dear

Health Board
Republic of Estonia

Present. -

I'm writing to you on behalf of the General Directorate of Medicines, Supplies and Drugs (DIGEMID, for its acronym in Spanish) of the Ministry of Health of the Republic of Peru, that asthe national regulatory authority responsible for guarantee the quality, safety and efficacy of pharmaceutical products, medical devices, and sanitary products in our country.

Likewise, on behalf of the International Affairs Area of DIGEMID, I´m contacting you on this occasion to make you aware that Digemid is in a recent institutional transformation context and in order to improve our processes we´re working on updating the database of the list of competent authorities that issue certificates of free sale or certificate authorizing the commercialization for medicines, biological products, and medical devices, including in vitro medical devices, established in Ministerial Resolution N° 169-2014-DIGEMID-DG-MINSA (attached in this communication).

For this reason, we kindly request your attention to the following queries:

• * Which is the competent authority to issue certificates of free sale or certificate authorizing the commercialization for medicines, biological products and medical devices, including in vitro medical devices?

• * What´s the position of the highest authority representing the institution competent to issue certificates of free sale or certificate authorizing the commercialization for medicines, biological products and medical devices, including in vitro medical devices?

In this regard, thanking you in advance for your attention to this matter, I look forward to your kind reply.

Kind regards.

Yours sincerely,