LEY NO 29459 PDF

  • April 26, 2019

Legal. Legal framework: Yes. Authorizing legislation: Ley N° Ley de Los Productos Farmaceuticos, Dispositivos Médicos y Productos Sanitarios (Nov. Relevant documents: Ley Nº ‑ Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Law No. on Pharmaceutical . Ley N° Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Law No. on pharmaceutical products.

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A total of anti-infectives were identified from ten community pharmacies in Arequipa, Peru. Articles Law of and D. Re-registrations The proportions for brand and generics were quite similar from to For the case study, data were collected from 10 retail pharmacies located in different socio-economic strata in the southern city of Arequipa, the second most industrialized and commercial city of Peru.

ley no 29459 pdf

On Peru, generics and branded generics are typically pharmaceutically equivalent but not bioequivalent to the originator. Number and proportion of brand and generic anti-infectives re-registered from to The awaiting registrations numbers gradually increased from to for both types of medicines.

The author read and approved the final manuscript. According to Rangel [ 7 ], this would provide better access to medicines while maintaining strong protection for innovation. Peruvian and non-Peruvian generic anti-infectives available at 10 pharmacies in Arequipa-Peru divided by socio-economic strata.

This cost did not include the opportunity cost of the time elapsed between the initiation of the procedure to obtain the marketing approval and the effective granting of the license. Also, 18 of these anti-infectives had a registration expiration date of ; 14 2459 a registration expiration date of ; and 9 had a registration expiration date of Regulation of article 50 of LawGeneral Health Law.


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Anti-infectives awaiting registration can be anti-infectives that have not submitted GMP certificates, have failed plant inspections, or have not yet presented pre-clinical or clinical studies to prove safety and efficacy. Acknowledgements The authors thank Dr. This requirement is also increasing the time needed to obtain marketing authorization. Availability of data and materials The data that support the findings of this study are available from the Peruvian Drug Regulatory Agency but restrictions apply to the availability of these data, and so are not publicly available.

The DIGEMID website index was used to update the information from the database until August for statuses 3 to 8 awaiting registration, expired, canceled, not approved, deserted or disregarded, and suspended registrations.

Two pharmacies each from different pharmacy chains, one located inside a private clinic were sampled in the districts of the high socio-economic stratum comprising a 1. Law 29, also includes chapters regarding universal access and rational use of medicines, promotion and research [ 14 ]. The non-Peruvian anti-infectives increased according to the socioeconomic stratum.

Prescription and use of antimicrobials evaluation study in ambulatory care at hospitals of the regional health directory-Lima. The proportions of brand anti-infectives new registrations were greater than the ones for generics throughout the study period, and this difference was even greater from to A study of the Brazilian pharmaceutical policy and access to essential medicines concluded that the goal of availability of essential medicines in the public sector has not been reached yet.

However, the other two strata showed an opposite behavior: Medicines in Peru are subjected to the following taxes: Of the anti-infectives with status 4 expired registration43 were brand mo 9 were ,ey products; and from these, 33 were of Peruvian origin and 19 of non-Peruvian origin.


There were 82 anti-infectives with statuses 4 to 8 found in the 10 retail pharmacies by August A comparison between the registration laws before and after the Free Trade Agreement presenting the main changes related to medicines. Branded generics are products with the same active ingredient s as an originator but are permitted to differ in shape, size, labeling, and excipients.

The agreement restricted the grounds for invalidating patents and set up rules for protecting test data submitted for marketing approval of medicines article Anti-infectives awaiting registration increased from 0 in to brand and generics in Situation of the medicines in Peru.

Although the registration fee and the cost associated with the new requirements can be considered modest by international standards, it might in fact become a market entry barrier for generic importers and domestic producers [ 16 ]. The public health sector is financed by subsidies indirect contributions and by social security direct contributions. Unfortunately, the use of these antibiotics for common pathologies increase the risk of bacterial resistance.

The following information was recorded: Received Apr 8; Accepted Sep The socio-economic strata were determined using the poverty level per district from a study based on a population census of [ 18 ]. The proportions for brand anti-infectives were Negotiation of future FTAs should prioritize access to high quality affordable medicines.