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)
European Pharmacopoeia (European Union)
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.