LEY NO 29459 PDF

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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In brand anti-infectives reached El enfoque de la pobreza monetaria]. Number and proportion of 2949 registrations of brand and generic anti-infectives from January to April Prescription and use of antimicrobials evaluation study in ambulatory care at hospitals of the regional health directory-Lima.

Whereas, the constitution protects free market competition and bans price control measures in the private sector.

ley no 29459 pdf

Conclusions and Recommendations This study found that the number of new registrations and re-registrations of anti-infectives dropped considerably after the implementation of the NDP in Table 5 Registry statuses of anti-infectives by socio-economic strata from 10 retail pharmacies 2459 Arequipa, Peru.

Competition issues in the distribution of pharmaceuticals. Anti-infectives found in pharmacies located in low-income areas were more likely to be generics, and less likely to be currently registered by DIGEMID. What is the impact of the NDP on the number of brand and generic anti-infectives registered in the country?

ley no pdf – PDF Files

Evidence for the decision making. 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. A study in Marchexamined 11 procedures required by the MoH for the marketing of pharmaceuticals.

Medicines are mostly distributed directly by the pharmaceutical manufacturers to hospitals and drugstore chains, also to large wholesalers, which mainly distribute brand imported medicines. nno

lej This drop is related to the longer time required for registration, the bioavailability and bioequivalence requirements, the GMP certificate requirement, and the first lot quality control defined by the NDP after the signing of the FTA. Evidencias para la toma de decisiones]. A total of anti-infectives were identified from ten community pharmacies in Arequipa, Peru. Category 3 other medicines: The retail pharmacy survey included anti-infectives.

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It is important to mention that The author read and approved the final manuscript. Published online Oct 24959 The awaiting registrations started with 48 niincreasing to in Many FTAs include provisions such as government procurement, competition policy, intellectual property IP rights protection, e-commerce, and more [ 2 ]. A case study was performed to determine the availability of anti-infectives at retail lye comparing these with the anti-infectives registered through DIGEMID.

On the other hand, two studies assessed the US-Jordan FTA and both concluded that the new data exclusivity regulation delayed generic entry and increased expenditures for medicines without generic competition [ 2324 ]. Microsoft Office Excel was used to perform descriptive statistics. Accessed 15 Feb The registration history included oey statuses: Small wholesalers mainly distribute medicines to independent private community pharmacies. This is confirmed by the results obtained from the 10 retail pharmacies in which almost the double of brand and generic anti-infectives were of Peruvian origin.

Executive office of the president U. Further studies could assess the effect of the FTA on the prices of medicines.

FTAs may provide opportunities for changes in regulatory systems and improving the safety, efficacy and quality of medicines. The lej of registrations that expired from to went down and then up; in there were expired registrations, in there wereand in there were Vitamin for the world economy.

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.

The proportions for brand anti-infectives were Office of the US Trade Representative.

Table 6 Characteristics of the 57 unique anti-infectives with statuses 4 to 8. 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. The higher proportion of Peruvian brand anti-infectives in the low and middle socioeconomic strata is an indication that these anti-infectives are branded generics, not originators. As of Octoberthere were 27 new chemical entities including 6 antivirals with enforced data exclusivity and 5 new chemical entities including 2 antivirals waiting for first time marketing license that have requested data exclusivity [ 27 ].

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The Supreme Decree —SA was issued to rule Lawparticularly the new requirements for the registration of pharmaceuticals, stating in part:. Reinforce monitoring and surveillance of retail pharmacies to control the quality of drugs marketed in the country. Articles Law of and D. Furthermore, this table shows the ATC classification for anti-infectives with statuses 4 to 8 found in the retail pharmacies.

Accessed 16 Apr Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Received Apr 8; Accepted Sep This could imply better acceptance of generics if the government informs the public about the improved quality of these medicines.

New registrations 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 However, when the data were compared to DIGEMID reports, which are performed at the national level, the results did not differ greatly. The anti-infectives mostly found were penicillins with extended spectrum, macrolides, cephalosporins, fluoroquinolones and combination of sulfonamides and trimethoprim the government covers the treatments for 2949 and tuberculosis in the public sector; this is why the majority of anti-infectives in the retail pharmacies were antibiotics.

Data are however available from the author upon reasonable request and with permission of the Peruvian Drug Regulatory Agency. The number of anti-infectives that were re-registered declined from in to 11 in Acknowledgements The authors thank Dr.