CONTENTS HEALTH LAW NEWSLETTER I MARCH, 2017 I “SIMPLEX” PROGRAMME ON MEDICINAL PRODUCTS 2 II NATIONAL COMMISSION OF PHARMACY AND THERAPEUTICS 3 III NATIONAL LEGISLATION 3 IV EUROPEAN LEGISLATION 5 NEWSLETTER I HEALTH LAW WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 2/6 HEALTH LAW NEWSLETTER I “SIMPLEX” PROGRAMME ON MEDICINAL PRODUCTS Within the context of the implementation of the Simplex + Programme, which aims for a transversal approach on the modernization of several sectors of the society and an easier connection between individuals, legal people and the State, it is available since 31 of March 2017 the new electronic platform of Infarmed, called “Licensing Portal +”. This platform centralizes every licensing procedure before Infarmed, referent to wholesale distribution of medicinal products and medical devices, manufacturing of medical devices and active substances, pharmacies’ activities, medicinal products intermediaries and public and private pharmaceutical services. This new tool will allow the licensing procedure to take place online and in a significantly faster way, enabling the applicant to have a transparent access to the different stages of evaluation and decision, once he can consult at any time the status of his application. In fact, Infarmed expects that by not having any more paper-based processes it could cut several months in its decision times. On the other side, it results as a major advantage of the dematerialization of the applications the clarification of which information the applicant must necessarily include, since that with the implementation of the Portal the licensing applications will be executed by the fulfilment of specific fields on a form online. Actually, according to the information disclosed by Infarmed, 80% of the processes presented were considered incomplete and therefore was necessary a request for further elements to the applicant, which represented the most relevant obstacle to the expediency of this Authority actions. In this way, after registration the Licensing Portal +, the entities are able not only to submit their licensing applications as well as consult and follow-up its development, proceed with the necessary payments, respond directly to any request by Infarmed for further information and receive the respective decisions, authorizations, licenses or certificates. Even though the Licensing Portal + is already available for entities of the pharmaceutical and medical devices sector, it is still only on the first stage of its implementation, as only after 21 of July 2017 it will be activated the functions for the applicants to access information about the status of their application, as well as for the public disclosure of information about professional and licenses entities. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 3/6 II NATIONAL COMMISSION OF PHARMACY AND THERAPEUTICS The National Commission of Pharmacy and Therapeutics (“CNFT”) was established in 2013 to act as advisory body of Infarmed in the quality of a specialized technical commission on the context of the promotion of an efficient use of medicinal products at a national level. Recently, with the intention of reinforcing the articulation between this entity and the Commissions of Pharmacy and Therapeutics (“CFT”) of the National Health System (“NHS”) hospitals and the Regional Health Authorities (“ARS”), the competencies and composition of the CNFT were redefined. Thus, on the one hand, the CFTs will be allowed to act as true points of contact and liaison bodies between CNFT and the healthcare services and establishments of the NHS, broadening their active role through the delegation of powers which allow them to intervene in matters that were originally within the CNFT scope, namely: (i) Power of the CFTs to propose to the CNFT what they deem as convenient within the matters covered by the scope of the competencies of the latter; (ii) Power of the CFTs to monitor the compliance with the criteria for the use of medicinal products in the respective hospital establishment or healthcare services, communicating periodically the results of said monitoring to the CNFT. On the one other hand, it is imposed to the CNFT the obligation of articulating with the CFTs for the purpose of collecting and monitoring the data pursuant to the use of medicinal products and other healthcare technologies within the context of the NHS. This reformulation aimed also the clarification of the role within the new structure of the National Medicinal Products Form, which is prepared by the CNFT, and consists in a tool to be used by the health services of the NHS on the promotion of a rational use of medicinal products, as it establishes the applicable criteria within the context of acquisition and use of medicinal products in the NHS. III NATIONAL LEGISLATION Reimbursements Order 92-E/2017 – D.R. No. 45/2017, 1s t Supplement, Series I of 2017-03-03 Establishes the regime of reimbursement by the State of the price of medical devices for the support of patients of incontinence or urinary retention, for beneficiaries of the National Health System. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 4/6 Order 92-F/2017 – D.R. No. 45/2017, 1s t Supplement, Series I of 2017-03-03 First amendment to the Order 284/2016, of 4 of November, which established the regime of reimbursement of medical devices, for the support of ostomate patients, for beneficiaries of the National Health System. Dispatch 2018/2017 – D.R. No. 49/2017, Series II of 2017-03-09 Determines the general and specific technical requirements applicable to medical devices for the support of patients of incontinence or urinary retention under the reimbursement regime. Dispatch 2019/2017 – D.R. No. 49/2017, Series II of 2017-03-09 Determines the maximum limit for the retail selling price for each group of medical devices, as well as the general and specific technical requirements applicable to medical devices for the support of ostomate patients under the reimbursement regime. “SPMS” – Shared Services of the Health Ministry Order 111/2017 – D.R. No. 54/2017, Series I of 2017-03-16 Second amendment to the Order 55/2013, of 7 of February, which defines the categories of specific goods and services in the health sector that have their public procurement contracts and acquisition procedures entered into and executed by the SPMS- Shared Services of the Health Ministry. Dispatch 2326/2017 – D.R. No. 55/2017, Series II of 2017-03-17 Determines that the SPMS – Shared Services of the Health Ministry publishes, in its website, all the characteristics of the products under public procurement contracts which establish the conditions of provision of antiretroviral medical products for the treatment of the HIV infection. Cystic Fibrosis Dispatch 1818/2017 – D.R. No. 43/2017, Series II of 2017-03-01 Creates the Coordinating Commission for the Treatment of the Cystic Fibrosis Disease (CCTDFQ), composed exclusively by healthcare professionals, having the mission of accompanying and monitoring the treatment of the cystic fibrosis disease. Dentistry Order 120/2017 – D.R. No. 59/2017, Series I of 2017-03-23 Approves the list of medicinal products that may be prescribed by dentists in the exercise of their professional activity. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 5/6 Transparency Dispatch 2166/2017 – D.R. No. 52/2017, Series II of 2017-03-14 Sub delegates to the Governing Boards of “Infarmed – National Authority for Medicinal and Health Products, Public Institute.” and the “Health System Central Administration, Public Institute.”, the powers to authorize the reception of benefits granted by companies that provide goods and services. “CFT” – Commissions of Pharmacy and Therapeutics Dispatch 2325/2017 – D.R. No. 55/2017, Series II of 2017-03-17 Determines the mission and approves the regulation of the Commissions of Pharmacy and Therapeutics (“CFT”) of the hospital entities of the public sector. Revokes the Dispatch 1083/2004, published on January 17. Order 126/2017 – D.R. No. 64/2017, Series I of 2017-03-30 First amendment of the Order 340/2012, of 25 of October, which regulates the evaluation and control mechanisms within the context of the prescription and dispensing of medicinal products, creates the Commissions of Pharmacy and Therapeutics of each Regional Health Authority (“CFT-ARS”) and establishes the respective duties, composition and functioning. IV EUROPEAN LEGISLATION New European rules for the inspection of clinical trials On March 25, the European Commission published the Regulation (EU) 2017/556 applicable to the procedures for the inspection of good clinical practice. This new diploma intends to complement the regulation on clinical trials of medicinal products for human use (Regulation No 536/2014 of the European Parliament and of the Council), in relation to the legal requirements applicable to the inspection procedures performed by the Member States. In this regard, the European Union recognizes that the compliance of the legal regime applicable to clinical trials will only be possible through the implementation of inspection procedures performed under the responsibility of the Member State where the inspection occurs. The Regulation 2017/556 defines the scope of the clinical trials subject to its application, defining the time limits and circumstances under which the planned inspections are supposed to occur. WWW.CUATRECASAS.COM NEWSLETTER I HEALTH LAW 6/6 The set of requirements applicable to the technical and professional qualification of the inspectors is a well-developed aspect of Regulation 2017/556, as well as the definition of the type of procedures which must be observed for the purposes of the inspection diligence act. The new European rules applicable to the clinical trials inspections will enter into force six months after the publication in the Official Journal of the European Union of the notice of the "Portal and the European Union Database", which lists all clinical trials existent in the European Union. This notice is foreseen under Regulation 536/2014. CONTACTS CUATRECASAS, GONÇALVES PEREIRA & ASSOCIADOS, RL Sociedade de Advogados de Responsabilidade Limitada LISBOA Praça Marquês de Pombal, 2 (e 1-8º) I 1250-160 Lisboa I Portugal Tel. (351) 21 355 3800 I Fax (351) 21 353 2362 email@example.com I www.cuatrecasas.com PORTO Avenida da Boavista, 3265 - 5.1 I 4100-137 Porto I Portugal Tel. (351) 22 616 6920 I Fax (351) 22 616 6949 firstname.lastname@example.org I www.cuatrecasas.com This Newsletter was prepared by Cuatrecasas, Gonçalves Pereira & Associados, RL for information purposes only and should not be understood as a form of advertising. 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