ESTUDIO DELION

HEALTH REGISTRATIONS IN PERU

Peruvian Health Registration before the General Direction of Medicines and Drugs-DIGEMID & Health Registration for these kind of products before the General Direction of Environmental Health DIGESA.

health registrations in PERU

Peruvian Health Registrations are regulated by the Ministry of Health and its two entities: the General Dire ction of Environmental Health DIGESA and the General Direction of Medicines and Drugs- DIGEMID.

So that the owner of any pharmaceutical or Cosmetic products can get the right to manufacture, trade or import these kind of products, he/she must apply for the Health Registration before the General Direction of Medicines and Drugs-DIGEMID.

Likewise, in order to the owner of any food products and industrialized beverages, can get the right to manufacture, trade or import these type of products, he/she must apply for the Health Registration for these kind of products before the General Direction of Environmental Health DIGESA

Estudio Delion includes within its staff prestigious professionals specialized in Pharmaceutical Chemistry , who work together with the lawyers of the firm, and provide personalized consultancy by means of Work meetings and Feasibility Studies , that allow us to understand the necessities of each particular case referring to Health Registration. This policy saves time and money because it decreases transaction costs and facilitate the taking of right decisions in a shorter time.

Services:

  • Health Registration for Foodstuffs. 
  • Health Registration for Pharmaceutical Products. 
  • Health Registration for Cosmetic Products. 
  • Physical-chemical and microbiological analysis. 
  • Compulsory Health Notification, only for Cosmetic   Products of the Andean Community. 
  • Integral Consultancy.

 

1º. Products which active principles are comprised in the National Register of Essential Medicaments

a) Request in the form of Affidavit, as per form; including the quail-quantitative formula, lifespan.

b) Specifications and analytic technique of the active principles and excipients: technical specifications of bottling and packaging materials; specifications and analytic technique of a terminated product using the following pharmacopeias in force as reference:

Pharmacopoeia of the United States of America (USP)

British Pharmacopoeia

European Pharmacopoeia (European Union)

Japanese Pharmacopoeia

WHO Pharmacopoeia

German Pharmacopoeia

Helvetica Pharmacopoeia

Belgian Pharmacopoeia

In the absence of the foregoing pharmacopoeias, the monograph of the product of the manufacturing country shall prevail.

The technical specifications shall be presented in an official document of the manufacturer or by a quality control laboratory certified by the competent authority of Good Manufacturing Practices or Good Laboratory Practices. In case the analytic technique does not correspond to any of the pharmacopoeias of the reference, the manufacturer must submit documents evidencing the validation of the characteristic analytic techniques.

c) Stability Studies.

d) Equivalence Studies (only for active principles according to the list published and updated by DIGEMID)

e) Labeling project in Spanish language of the intermediate, immediate packing and insert, when appropriate.

f) Certificate of Pharmaceutical Product issued by the competent authority of the country of origin or from the exporter based on the form of the World Health Organization (WHO) for imported products;

g) Certificate of Good Manufacturing Practices (GMP) of the local or foreign manufacturer issued by the health authority in Peru . A Certificate of Good Manufacturing Practices of a foreign manufacturer shall have a term of one year to be applied. During such term, the National Health Authority will accept Certificates of Good Manufacturing Practices issued by the competent Authority of the country of origin.

A Health Registration procedure of medicaments in this category takes a term no lower than forty five (45) days and no longer than sixty (60) calendar days.

2º Products which active principles are not found in the National Register of Essential Medicaments and are registered in countries with high health inspection. In addition, products which active principles have been registered in Peru under category 3 as from the date in which this regulation comes into force.

In order to be registered in the Health Registration, besides the requirements set forth in number 1°, it is also necessary to submit information about the efficiency and safety of the active principle in case of a single-medicament formula or information about the association in case the product has more than one active principle.

In the cases of products comprised in number 2° which are referred to chemical institutions, subject to the protection of assay data which have not been approved in Peru and which have been approved in a country of high health inspection, it is also important to submit an affidavit indicating that the applicant is the person that produced them or that is authorized to use them.

Medicaments having obtained assay data protection or safety and efficacy protection which are not disclosed in countries practicing high health inspection may only resource to the health registration procedure set forth in number 2°.

For purposes of numeral 2°, the following are countries practicing high health inspection: France , Netherlands , United Kingdom , United States of America , Canada , Japan , Switzerland , Germany , Spain , Italy , Belgium , Sweden , Norway , Australia , Denmark .

A Health Registration procedure of medicaments in this category takes a term no lower than forty five (45) days and no longer than sixty (90) calendar days.

 

3º. Products which active principles are not within categories 1° and 2°

In order to be registered in the health registration, in addition to the documents set forth in number n°1, except for the equivalence studies, any studies and documents that support the efficacy and safety of the product.

A Health Registration procedure of medicaments in this category takes a term up to twelve (12) months.


1) Request in the form of Affidavit directed to the General Director of DIGESA. This request must be duly signed by the Legal Representative and include the components of the product, packaging materials, preserving conditions, lifespan, batch coding system), as well as the Distributor and Manufacturer's data.

2) Physical, chemical and microbiological analysis of the end product, confirming it is fit in accordance with the health regulations in force, granted by a laboratory authorized by INDECOPI or by the Manufacturer's quality control laboratory.

3) Certificate of Free Sale or the like or Health Certificate issued by the competent authority of the country of origin, in original or copy duly legalized by the Peruvian Consulate in case the food or beverage was imported.

4) Label of the products labelled.

5) The Food and Beverages of special regimens, shall mention their nutritional properties enclosing the respective bromatological analysis performed by a laboratory authorized by INDECOPI.

6) Affidavit stating the applicant is a micro or small business (MYPE), if this the case.

7) Validation Certificate of natural resource and product, for its use in health, granted by the Intercultural Health Centre-CENSI.

Closely held corporation ("sociedad anónima cerrada") :

It must include twenty (20) shareholders , as maximum. It can be incorporated in such a way that the General Manager would be empowered will full powers in the name of the corporation. This would speed up the management of the enterprise, however it would provide a less supervision on it.

Therefore, the shareholders must appoint as a manager a person of their total trust. An only one way of controlling would be that the manager can be removed from his position at any time and without any explanation from the Board of Directors. Moreover, has not been registered before the Public Registry of Securities Market.

In case it is wished to incorporate a closely held corporation ("sociedad anónima cerrada") with a Board of Directors, it is only needed the identification data of the manager and/or managers.

Requirements :

Documents, prosecution, and terms are the same than the ones outlined above for the publicly-held corporation ("sociedad anónima abierta").