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