Life Sciences Newsletter – July 2019

LIFE SCIENCES NEWSLETTER

BILL: GENERIC DRUGS AND BIOSIMILARS

Executive Branch sent the bill “Act declaring drugs, biological products and medical devices as essential part of right to health and provides measures to guarantee their availability” to the Congress for review. This bill provides that strategic health resources are those pharmaceutical products, medical devices and sanitary products recognized as essential in the Peruvian Essential Medicines List by the Ministry of Health.

The bill seeks to implement the following main provisions:

• Measures to promote the use of generic drugs and biosimilar products in order to improve the access to them by the population. It should be mentioned that the use of generic drugs and biosimilars itself is a good option provided that generic drugs have interchangeability study, and biosimilars meet health/sanitary standards established in the pertinent regulation, so this would guarantee products safety and efficacy. These matters should be detailed in the bill.
• The Ministry of Health may, through the Pan American Health Organization (PAHO/WHO), the United Nations International Children’s Emergency Fund (UNICEF) and United Nations Population Fund (UNFPA), acquire strategic health resources upon technical report showing advantages and benefits of the agreement between such international organizations.
• Obligation to report on temporary and definitive discontinuation of drug and biological product manufacturing and import. This provision applies to holders of sanitary/health registration and valid sanitary/health registration certificate of domestic and imported drugs and biologic products.
• The Ministry of Health may approve the essential medicines list that must be available for pharmacies, drugstores and private-sector pharmacy services.

GENERAL MEDICINE, SUPPLIES AND DRUG ADMINISTRATION (DIGEMID)

TECHNOVIGILANCE FORMS

By virtue of Ministerial Order No. 101-2019-DIGEMID-DG-MINSA published in the Official Gazette “El Peruano”, forms of suspicion of medical devices adverse incidents notice by holders of sanitary/health registration and sanitary/health registration certificate, and health professionals were approved.

These forms are published in compliance with Items 6.7 and 6.8 of the Technical Standard for Health (NTS) No. 123-MINSA/DIGEMID-V.01 regulating Pharmaceutical Products, Medical Devices and Sanitary Products Pharmacovigilance and Technovigilance activities.

Click here:

http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2019/RM_101-2019-DIGEMID-MINSA.pdf

GOOD LABORATORY PRACTICE TECHNICAL GUIDE

By virtue of Ministerial Order No. 506-2019/MINSA, Technical Guide: Good Laboratory Practice Inspection Guide for the Quality Control of Pharmaceutical Products was approved.

Said Guide applies to laboratories exclusively engaged in control quality analysis of pharmaceutical products, pharmaceutical products laboratories providing quality control analysis services, and drugstores having a quality control laboratory of pharmaceutical products.

This Guide shall be applicable as of July 24, 2019 together with the Good Laboratory Practice Manual for the Quality Control of Pharmaceutical Products.

Click here:

https://cdn.www.gob.pe/uploads/document/file/319892/Resoluci%C3%B3n_Ministerial_N__506-2019-MINSA.PDF

PUBLICATION OF DIRECTOR’S ORDERS ON DIGEMID WEBPAGE

On May 27, on DIGEMID webpage, the list of Director’s Orders regarding fine imposed on those subject to these regulations was published by the DIGEMID Division of Inspection and Certification.

Such list is composed by 50 companies with sanctions issued in October 2018 and February, March and April 2019.

Click here:

http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C22_2019-05-27.pdf

 REDUCTION OF ADMINISTRATIVE FEE AND REQUIREMENTS SIMPLIFICATION

The Ministerial Order No. 431-2019/MINSA provides reduction of formalities fee of 116 administrative procedures by DIGEMID established in the Consolidated Text of Administrative Procedures (TUPA) of the Ministry of Health. These fee reduction includes registration and re-registration procedures of pharmaceutical products, medical devices and cosmetics. Certification procedures are also included.

Furthermore, 13 requirements of the following re-registration procedures below are simplified:

• Sanitary/Health Registration of Natural Therapeutic Resources (Tupa 69)
• Sanitary/Health Registration of Homeopathic Products (Tupa 70)
• Sanitary/Health Registration of Dietetic Products and Sweeteners (Tupa 71)
• Sanitary/Health Registration of Galenical Products (Tupa 74)

Click here:

https://cdn.www.gob.pe/uploads/document/file/314222/Resoluci%C3%B3n_Ministerial_N__431-2019-MINSA.PDF

GENERAL ENVIRONMENTAL HEALTH AGENCY (DIGESA)

CHANGE OF THE GENERAL DIVISION CHIEF

By virtue of Ministerial Order No. 548-2019/MINSA, Mirtha Rosario TRUJILLO ALMANDOZ is appointed as Chief of the Environmental Health and Food Safety General Division of the Ministry of Health.

Click here:

https://busquedas.elperuano.pe/download/url/designan-directora-general-de-la-direccion-general-de-salud-resolucion-ministerial-no-548-2019minsa-1780577-3

NATIONAL SERVICE FOR AGRICULTURAL HEALTH (SENASA)

AMENDMENT TO DECISION 483 OF VETERINARY PRODUCTS

On April 29, 2019, Decision 838, amending Decision 483, that regulates the Registry, Control, Marketing and Use of Veterinary Products, was published in the Official Gazette of the Cartagena Agreement.

Country Members have recognized the need to update the regulation in matters of registry and control of veterinary products, considering that application aspects of Andean Decision 483 that should be amended have been identified in order to facilitate the registration, control and marketing of veterinary products of the Andean region.

Sections 32, 34, 37, 39, 41, 43, 47, 59, 62, 63 and 94 are amended. Likewise, the following definitions are included in Exhibit I: Quality Control Certificate, Certificate of Free Sale, Stability Testing, Shelf-Life, and Biological Product.

Click here:

http://www.comunidadandina.org/DocOficialesFiles/Gacetas/Gaceta%203602.pdf

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