The Spanish Council of Ministers have approved the amendment of Royal Decree nº1345/2007, of October 11, regarding the procedure of authorization, registration and dispensing of medicines for human use which are industrially manufactured, by virtue of Royal Decree nº717/2019, of December 5.
Last December 5, 2019, the Spanish Council of Ministers approved Royal Decree number 717/2019 by means of which it amends Royal Decree number 1345/2007, of October 11, regarding the procedure of authorisation, registration and dispensing of medicines for human use which are industrially manufactured. The purpose of such amendment is to update some of the provisions regarding the authorization and commercialization of medicines for human use. This update affects the need to hold a track record of the effective commercialization of the medicines for human use which have been authorized authorized for commercialization by the Spanish Agency of Medicines and Medical Devices (in Spanish, "Agencia Española de Medicamentos y Productos Sanitarios - AEMPS -"), the need to respond to the increasing concerns for commercialization of homeopathic products, as well as the obligation to adapt the Spanish legislation on medicines for human use to European regulation on prevention of falsification and/or tampering of medicines for human use.
The main changes to the current Spanish Royal Decree number 1345/2007 can be summarized as follows:
1. Derogation of the category of Medicines of Special Medical Control. The reason for this derogation is that the AEMPS understand that the current pharmacovigilance obligations are sufficient to control these medicines, such as the obligation of the specialized healthcare professionals to carry out special surveillance during the treatment of the patients. One of the main implications of such derogation is that the restriction on the pharmacist not to substitute the medicines prescribed by the healthcare professional without the express authorization of the healthcare professional in the case of Medicines of Special Medical Control will no longer be applicable.
2. Reinforcement of the obligations of the holder of the authorization for commercialization regarding market supply. The marketing authorization holder (in Spanish, "Titular de la autorización de comercialización - TAC -") is obliged to permanently keep the Spanish Registry of Medicines for human use updated on the status of commercialization of the relevant authorized medicine for human use and is also obliged to notify to the AEMPS any unusual restriction on the supply of medicines and, where such restrictions may have an adverse impact, the TAC will have to cooperate with the Spanish Agency to mitigate such impact. Additionally, where the TAC wishes to suspend or to cease the commercialization of the relevant medicine for human use, it will have to give a six (6)-month prior notice, instead of the former two (2)-month prior notice.
3. Procedure of authorization for commercialization of homeopathic medicines for human use. It is clarified that homeopathic medicines for human use with approved therapeutic indications will be subject to the standard review, authorization and registry procedure set out for medicines for human use. That is, in order to be authorized, they will be subject to the same criteria applied for other medicines for human use, such as the need to provide the results of clinical trials to support the request for a marketing authorization.
4. Vaccines subject to prior manufacturing authorization and to ex-post commercialization approval. The scope of vaccines subject to prior manufacturing authorization and to ex-post commercialization approval by the Spanish Agency of Medicines and Medical Devices is extended to all kind of vaccines. Formerly, such authorization and approval requirements were only set out for specific kinds of vaccines, i.e., viral vaccines, vaccines against tetanus, diphtheria and pertussis both monovalent and polyvalent, and for the attenuated anti-typhoid vaccine.
5. Addition of specific provisions on prevention of falsifications and tampering of medicines for human uses. A new full Chapter IX is included in Royal Decree number 1345/2007, in order to adapt the same to current European provisions on prevention of falsification and tampering of medicines for human use, which mainly foresee for specific medicines for human use the obligation to include a unique identifier and an anti-tampering device. This Chapter IX regulates the verification and authentication system for medicines for human use.
Summarizing such Chapter IX, it mainly refers to the following aspects: (a) that it is the authority of the Spanish Ministry of Health, Consumer and Social Welfare to set out which medicines are subject to these security provisions; (b) that the scope of medicines subject to such security obligations for purposes of pharmacovigilance, security and reimbursement is extended; (c) that entities distributing these medicines may also be subject to the obligation to verify the authenticity and non-tampering of these medicines if so requested by the Spanish Agency of Medicines and Medical Devices; (d) the obligation to disable these two elements where medicines are to be distributed within the benchmark of public healthcare programmes developed by healthcare authorities; (e) obligations in relation to imported medicines for human use; and (f) provisions regarding the national repository to be used to verify the authenticity of the unique identifiers of the medicines for human use commercialized in Spain.
Finally, the Royal Decree creates a specific node for the Healthcare National System (in Spanish, "Sistema Nacional de Salud") called "Nodo SNSFarma" so that the pharmaceutical service of the Healthcare National System is consistent with European provisions on verification of authenticity and prevention of tampering of medical devices. Such node will allow to exchange information with the aforesaid national repository regarding medicines for human use, including a unique identifier and which are covered by the Healthcare National System.
Access to Royal Decree number 717/2019 can be obtained in the following link: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2019-17611