Life Sciences Newsletter – January 2020


DIGEMID: List of generic drugs that must be kept available in pharmacies and drugstores

Through Ministerial Resolution No.1097-2019/MINSA, the list of Essential Generic Drugs in The international nonproprietary name (INN) contained in the National Single Request for Essential Medicines (PNUME), which must be kept available in private pharmacies and drugstores, was published.

In this regard, Digemid issued a statement confirming that said list contains 4 psychoactive drugs of the list of Schedule IV drugs of the substances regulation subject to sanitary control (Supreme Decree No. 023-2001-SA). Drugs contained in the aforementioned list of Schedule IV drugs do not require the presentation of the quarterly balance sheet, the official control book should not be carried out and for attention, common medical prescription is required specifying that it must be held for 2 years in the pharmaceutical establishment.

Click here to see the ministerial resolution.

Click here to see the statement.

DIGEMID: List of medical devices that do not require health registration

Digemid published on its website the list with a total of 1095 medical devices that do not require health registration to be imported, manufactured and marketed in Peru.

The aforementioned list includes corrective lenses, manual toothbrush, electric toothbrush, heart rate monitor, orthopaedic belts, facial vaporizers, manicure kits, among others.

Click here to see the document.

DIGEMID: Good Pharmacovigilance Practices Project

Through Ministerial Resolution No. 001-2020/MINSA, the manual of the Good Pharmacovigilance Practices project was published and a period of 30 calendar days was granted to submit suggestions, comments or recommendations to the document through the following email:

Click here to see the document.

DIGEMID: List of foreign manufacturers pending to be certified in BPM

Through Official Letter No. 2367-2019, Digemid informed Customs the list of foreign drug manufacturing laboratories that are pending of certification in Good Manufacturing Practices (BPM) by the Peruvian authority. This list must be reviewed by Customs in the process of importing medicinal products.

Click here to see the document.

For further information on these topics, you can contact Maritza Reátegui and Solange Noriega of the Life Sciences practice group.