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Life Sciences Alert – July 2019

ALERT – LIFE SCIENCES

Amendment to Drug Establishments Regulation

By virtue of Supreme Executive Order No. 016-2019-SA dated June 29, the Ministry of Health and the Ministry of Economy and Finance caused to amend the Drug Establishments Regulation in compliance with the regulations of administrative simplification.

In this regard, some of the most important amendments are presented below as follows:

Additionally, the following supplementary provisions are set forth in below:

Warehouse relocation:

a) Wholesaler/Distributor or specialized drug warehouse holding a Good Storage Practices Certificate in effect. In the event they request warehouse relocation or expansion, upon pertinent Health Authorization, DIGEMID updates the Certificate scope remaining in effect.

b) Laboratory holding a GMP Certificate in effect. In the event it requests plant or manufacturing areas relocation or expansion, upon pertinent Health Authorization, DIGEMID issues a GMP Certificate in respect to such relocated or expanded areas, with a 1-year effective term.

c) Laboratory holding a GMP Certificate in effect. In the event it requests warehouse or quality control area relocation or expansion, upon pertinent Health Authorization, DIGEMID updates the Certificate scope remaining in effect.

Temporary regulation

a) Administrative procedures having started prior the effective day of the amendment, are governed by the previous regulation up to their conclusion.

b) Notwithstanding, provisions of the Supreme Executive Order recognizing rights and powers of the entities subject to these regulations before the pertinent Administration are applicable to the procedures in progress.

For further details, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and/or Solange Noriega (snoriega@estudiorodrigo.com)