The Specialized Room for the Elimination of Bureaucratic Barriers of Indecopi ruled against the Ministry of Health (Minsa) and declared the requirement to periodically renew the Certificate of Good Practices of the Pharmaceutical Office an illegal bureaucratic barrier.
In this way, resolution 0501-2023/SEL-INDECOPI declares as a barrier the provisions of Article 127 of the Regulation of Pharmaceutical Establishments approved by Supreme Decree No. 014-2011-SA.
This decree, in force for more than a decade, required that pharmaceutical establishments (apothecaries and pharmacies) must process the renewal of their Certification of Good Pharmaceutical Practices 6 months after having obtained it for the first time and then, every 3 months thereafter. years.
However, Indecopi resolved that, while said certification constitutes an enabling title, “it must be granted with indefinite validity, that is, it must not be subject to a deadline, unless so determined by a norm of legal rank or supported by a supreme decree”, in accordance with the aforementioned regulatory framework.
“Given that the Ministry of Health does not have the legal authority to impose a specific validity period for the Certification of Good Practices, nor has it proven to have supported, through a supreme decree, the establishment of a specific validity period for the aforementioned certification, the imposition of the indicated measures is illegal for contravening the provisions of article 42 of the Single Ordered Text of Law 27444, Law of General Administrative Procedure”, maintains the Chamber.
The resolution by Indecopi does not exempt pharmacies and pharmacies from their legal obligation to have the certificate and maintain permanent compliance with Good Storage, Dispensing and Pharmacotherapeutic Monitoring Practices, in accordance with the provisions of article 22 of the Law 29459, Law on Pharmaceutical Products, Medical Devices and Health Products.
The ruling also does not ignore the powers of subsequent inspection that the competent Administrative Authorities have to verify said compliance.
Source: Larepublica
Alia is a professional author and journalist, working at 247 news agency. She writes on various topics from economy news to general interest pieces, providing readers with relevant and informative content. With years of experience, she brings a unique perspective and in-depth analysis to her work.
