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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Furthermore, in some cases, they are only pharmaceutical alternatives such as different salts, esters or complexes; or different dosage form or strengths but are prescribed or dispensed as interchangeable with the originator. The previous system only required an affidavit proving safety, efficacy and quality.
In Peru, generics and branded generics are typically pharmaceutically equivalent but not bioequivalent to the originator. The agreement restricted the grounds for invalidating patents and set up rules for protecting test data submitted for marketing approval of medicines article NISS provides free health care and medicines exclusively for salaried workers and their family members in their own hospitals and clinics.
The registration expiration date and the ATC pharmacological-chemical class were determined for products with statuses 4 to 8. New registrations for brand and generic anti-infectives decreased from to to 60 and to 20 respectively.
What is the impact of the NDP on the number of brand and generic anti-infectives registered in the country? A study in Marchexamined 11 procedures required by the MoH for the marketing of pharmaceuticals.
A total of anti-infectives were identified from ten community pharmacies in Arequipa, Peru. Identification of provisions of the public administration that affect the private investment in the trade sector: New registrations Leh 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 Both author read and approved the final version to be published.
The data were collected from July 30 to August 15, The private sector sells services to NISS in their clinics and doctor offices. Medicines applying for re-registration may continue in the 92459 until the final decision is made.
Table 5 Registry statuses of anti-infectives by socio-economic strata from 10 retail pharmacies at Arequipa, Peru. Number and proportion of brand and generic anti-infectives re-registered from to In contrast, the proportions for generics were Support Center Support Center. The Law stipulates the time allowed to review applications and grant marketing approvals according to the new categories of medicines:.
Descriptive statistics and chi-square test were used for the analysis.
Anti-infectives awaiting registration increased from 0 in to noo and generics in One of the pharmacies from this stratum is located in a clinic where most of the patients have private insurance; therefore, the pharmacy mostly sells originator products. The number of registrations that expired from to went down and then leu in there were expired registrations, in there wereand in there were In brand anti-infectives reached J Pharm Policy Pract.
Rapid evaluation -with indicators- of the national pharmaceutical situation.
ley no pdf – PDF Files
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. There is a need for implementing a comprehensive Generic Drug Policy, as part of the NDP, and inform the public how the new regulations will improve the safety, efficacy and quality of generics.
Articles Law of and D. The Peruvian health care system is divided into public and private sectors.
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Medicines are mostly distributed directly by the pharmaceutical manufacturers to hospitals and drugstore chains, also to large wholesalers, which mainly distribute brand imported medicines. However, when the data were compared to DIGEMID reports, which are performed at the national level, the results did not differ greatly.
The majority were the combination of sulfonamides and trimethoprim followed by penicillin with extended spectrum and penicillin with beta-lactamase inhibitors as well as fluoroquinolones. Furthermore, although growth in overall consumption of medicines is explained mainly by the public health sector, the total cost of such consumption is more related to consumption by the retail private sector [ 16 ]. Regulatory changes may occur without external changes, however, it may be difficult to reach a consensus with the pharmaceutical market stakeholders.
Statistical analyses Microsoft Office Excel was used to perform descriptive statistics.