CLOSE

LAWYERS

SEARCH BY ALPHABETICAL ORDER

SEE ALL LAWYERS
CLOSE

PRACTICE AREAS

Life Sciences Newsletter – March 2019

LIFE SCIENCES NEWSLETTER

Lima, March 14, 2019

E-HEALTH No. 01

Life Sciences & Health Care

 

REGULATIONS:

TECHNICAL STANDARD FOR HEALTH REGULATING MINIMUM DATA FOR IN-HOUSE ANALYTICAL TECHNIQUES VALIDATION

The Ministerial Order No. 234-2019/MINSA was published in the Official Gazette “El Peruano”. This Ministerial Order approved the Technical Regulation for Health (NTS) No. 147-MINSA/2019/DIGEMID that regulates minimum data to be included in the document for in-house analytical techniques validation.

This regulation shall be mandatory for requests of registration, reregistration, and health registry amendment submitted as of the effective day.

The regulation shall come into force this September.

Click here to view the document:

https://cdn.www.gob.pe/uploads/document/file/298618/Resoluci%C3%B3n_Ministerial_N__234-2019-MINSA.PDF

 

TECHNICAL DOCUMENT FOR HEALTHY FOOD PROMOTION AND PROTECTION 

On Saturday, March 2, the Ministerial Order No. 195-2019/MINSA was published in the Official Gazette “El Peruano”. This Ministerial Order approved the Technical Document: Guidelines for Healthy Food Promotion and Protection in Public and Private Schools of Basic Education System.

The purpose of this document is to promote and protect healthy food for children and adolescents of public and private schools of Basic Education System.

Some general aspects are provided for as follows:

  • Urge school authorities so stands, cafés and dining halls sell and promote the consumption of healthy food and beverages.
  • Give technical assistance to strengthen healthy food promotion skills.
  • Create planning groups among ministries to ensure: healthy and sanitary conditions in schools, food and beverage supply, adequate storage, etc.

The regulation sets aside the Ministerial Order No. 161-2015/MINSA, Health Directive for Promotion of Healthy Stands and Dining Halls in Schools.

Click here to view the document:

https://cdn.www.gob.pe/uploads/document/file/296301/RM_N__195-2019-MINSA.PDF

 

NEWS:

 

NEW EXECUTIVE DIRECTORS IN THE GENERAL MEDICINE, SUPPLIES AND DRUG ADMINISTRATION (DIGEMID)

By virtue of Ministerial Order No. 236-2019/MINSA published in the Official Gazette “El Peruano”, the resignations of Executive Directors are accepted and new Executive Directors are appointed for the following departments of the General Medicine, Supplies and Drug Administration (DIGEMID):

Department New Officer Former Officer
Department of Pharmaceutical Products Sandra Del Pilar González Arana, Chemist Ana Gabriela Silva Flor De Olórtegui, Chemist
Department of Medical Devices and Health Products Lida Esther Hildebrandt Pinedo, Chemist Julio Américo Salas Carnero, Chemist
Department of Inspection and Certification Marisa Angélica Papen Bernaola, Chemist Eldey Mary Acuña Morillo, Chemist
Department of Pharmacovigilance, Access and Use Maruja Crisante Núñez, Chemist Yvonne Magali Llatas Gonzáles, Chemist

Click here to view the document:

https://busquedas.elperuano.pe/download/url/aceptan-renuncias-y-designan-profesionales-en-la-direccion-g-resolucion-ministerial-n-236-2019minsa-1749193-3

 

DOMESTIC DONATIONS

As per online communication on its webpage, DIGEMID establishes that donations of pharmaceutical products, medical devices and health products must be in compliance with requirements of the recipient entity. Donations must meet the following items:

  • Donated only by laboratories and drug stores
  • Health registry in force
  • Minimum expiration date of 6 months at the time of receiving donations. As an exception, donations with date less than expiration date may be received provided that the recipient entity expressly states so by an affidavit.
  • Donations in good conditions, with no evidence of having been opened or partially used.
  • Not being under quality and/or safety alert issued by DIGEMID

Click here to view the communication:

http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C06_2019-02-25.pdf

 

NEW EXTRAORDINARY IMPORT AUTHORIZATION FORM

DIGEMID communicated on its webpage the new version form of Extraordinary Pharmaceutical Products Import Authorization for Prevention and Individual Treatment. Forms are available as of February 27 and its application as of this February 28.

Click here to view the communication:

http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Comunicados/2019/C08_2019-02-28.pdf

 

NEW FDA REGULATION FOR SUNSCREENS

As per online press release, FDA communicated the new regulation updating control requirements for most of sun protection products in the United States.

By virtue of its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements.

Among the most outstanding proposals, the regulation:

Proposes that, of the 16 currently marketed active ingredients, two ingredients – zinc oxide and titanium dioxide – are generally recognized as safe and effective for use in sunscreens; two ingredients – para-aminobenzoic acid and trolamine salicylate – are not generally recognized as safe and effective due to safety issues.

Proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.

Proposes to require sunscreens with an SPF value of 15 or higher to also provide broad spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases.

Click here to view:

https://www.fda.gov/NewsEvents/Newsroom/ComunicadosdePrensa/ucm631930.htm