Cerrar

On 3 June 2022, Supreme Decree No. 009-2022-SA ("DS 009") was published in the Official Gazette, El Peruano. DS 009 establishes various measures for facilitating the regulation of pharmaceutical products (including biological products).

The measures are as follows:

  1. The Good Manufacturing Practices (BPM) certificates issued by both the competent authorities of the country of origin of the product and by DIGEMID, for the import and registration of pharmaceutical products manufactured abroad, will be valid until 23 May 2023.
     
  2. The BPM certificates issued by DIGEMID to foreign pharmaceutical laboratories will be valid as long as the COVID-19 Health Emergency remains in force.
     
  3. Notwithstanding the foregoing, DIGEMID may require information related to BPM compliance. This information must be sent within 10 business days.
     
  4. Exceptionally, DIGEMID will accept until 31 December 2022 the registration, re-registration and changes in the sanitary registration of pharmaceutical products manufactured abroad, and BPM certificates from countries with high health surveillance and from the country of origin — the term of which expire between 11 March 2020 and 30 December 2022 — provided that these countries have extended the validity of these certificates.
     
  5. Exceptionally, SUNAT/CUSTOMS will accept until 31 December 2022 the import of pharmaceutical products manufactured abroad, and BPM certificates from countries with high health surveillance and from the country of origin — the term of which expire between 11 March 2020 and 30 December 2022 — provided that these countries have extended the validity of these certificates.
     
  6. DIGEMID will issue, "through formal communication," documents that can be submitted in English, for the purposes of registration or re-registration of products in the health registry.
     
  7. Regarding the conditional registration of biological products, if they were registered using labeling and inserts in English, said documents must be in Spanish language at the first re-registration.
     

We trust that this information will be useful to you and your company. If you require legal advice on this issue, do not hesitate to contact us.

Last News