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Life Sciences Newsletter – September 2019

LIFE SCIENCES NEWSLETTER

GENERAL MEDICINE, INPUT AND DRUG ADMINISTRATION (DIGEMID)

RISK MANAGEMENT PLAN

Pursuant to Ministerial Order No. 796-2019-MINSA, it is set forth to approve the Technical Standard for Health (NTS) No. 156-MINSA/2019/DIGEMID. It regulates the preparation of the Pharmaceutical Products Risk Management Plan.

This Technical Standard is enforceable to the holder of sanitary/health registration of pharmaceutical products. It does not apply to medical gases, herbal medicines, dietetic products, sweeteners and galenical products.

It will come into effect as of March 2020.

Click here.

GMP INSPECTION GUIDE

Pursuant to Ministerial Order No. 779-2019MINSA, it is set forth to approve the Good Manufacturing Practice Inspection Technical Guide to Pharmaceutical Products.

The inspection guide will be applied to domestic and foreign laboratories manufacturing pharmaceutical products. It does not applied to herbal medicines.

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DIGEMID PRESS ANNOUNCEMENTS

SPECIAL PRESCRIPTION PADS

Physician or dentist registration declaration form for special prescription pads shall be submitted to DIGEMID reception desk.

Click here.

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