49
Edition nº
Infarmed elected to Coordinating Committee
of the European Network of Official Laboratories
At the annual OMCL (Official Medicines Control Laboratories) meeting in Budapest on 15-19 May, Infarmed was elected as a member of the Coordinating Committee of this European Network of Official Quality Assurance Laboratories (General European OMCL Network Advisory Group).
The GEON Advisory Group coordinates the European activities of laboratory testing of medicinal products within the 58-member OMCL network and 11 associates and integrates, in addition to the official drug testing laboratories of the European Union / European Economic Area, countries such as Switzerland, Canada, Israel and Singapore.
GEON was established in 1995 within the framework of the Council of Europe and its main objective is to coordinate the independent laboratory control carried out by official laboratories.
The Laboratory of Infarmed remains one of the OMCLs with a high level of participation at European level. It was the 4th laboratory to carry out the laboratory control of more MRP / DCP medicines, and the 6th laboratory with the most blood products analyzed in the scope of the release Batch officer.
Updating platforms for
Medical Device Registration
In order to facilitate and simplify its use, the Infarmed medical device registration platforms by manufacturers and agents (FABDM) and by distributors (SDIV) have been updated.
In the case of the FABDM platform the advantages will be the filling of references in block, the possibility of managing the data offline and also, the reduction of the time necessary for the registration and changes.
In the SDIV platform the main changes are the possibility of assigning in block of a same code NPDM (Portuguese Nomenclature of the Medical Device) to all the references of a same register of medical device, being possible also to load this information through a file CSV and the possibility of obtaining an immediate declaration of registration of the medical device, for medical devices that do not yet have a Medical Device Code (CDM). This statement states that the wholesale distributor has notified Infarmed of the medical devices it has marketed. There is also the possibility of obtaining an immediate declaration of an ongoing codification procedure. This statement is issued for medical devices that do not yet have CDM for the purpose of public tender.
Project Simplex +
A video of the 9 measures implemented last year under the Simplex + 2016 Program is available on the Infarmed website.
With a central concern to simplify access to information and electronic submission and management of processes, these measures cover a diverse range of areas, ranging from health care providers and clinical trial promoters to distributors and pharmacies, thus seeking to be increasingly close to the citizen, health professionals and all agents of the sector.
The nine measures implemented were: Portal CAUL - Applications for Authorization of Vaccines and Blood Derivatives; ADMED - Direct Acquisition of Simpler Drugs; POUPE NA RECEITA - New version of the app that allows the user to save on the cost of their medicines; CDM - Simpler access to medical device information; RNEC - Registration and submission of applications for clinical trials; SMUH - Electronic submission of applications for Marketing Authorizations (MAH), amendments and renewals; PRESENT AUTHORIZATIONS - Submission and electronic process management and expenditure monitoring; SIATS - Management of the marketing circuit of drugs and LICENCIAMENTO + - Submission and electronic management of licensing processes.
These tools are available in the Online Services area of the Infarmed website (Portuguese Version). See the informational video on these 9 measures.
App Poupe na Receita
Infarmed makes available today an informative video about "Poupe na Receita ", a free mobile application that allows users to save money on the purchase of medicines by identifying the cheapest options.
This video, published on the website and social networks of Infarmed (Twitter and LinkedIn), aims to demonstrate in a simple way the different features offered and the advantages of its use.
Since 2016, this application registers a total of 132,699 downloads made through the two operating systems available, iOS and Android. In the iOS system the total downloads is 81,840 and in the Android system is 50,859 which represents a strong adhesion of the citizens to the advantages allowed by the application.
Learn more about "Poupe na Receita" through the website or watch the new informational video.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Parque de Saúde de Lisboa - Avenida do Brasil, 53, 1749-004 Lisboa - Portugal
Telef: +351 217 987 100 | Fax: +351 217 987 316 | E-mail: Infarmed@Infarmed.pt