PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
includes obtaining consent, fulfilling information obligations, ensuring the security of the process- ing, establishing joint controllership or sub-pro- cessing agreements, and complying with regula- tions regarding international data transfers. If the resulting data is anonymised, then those GDPR requirements do not apply. 2.6 Databases Containing Personal or Sensitive Data The GDPR requirements regarding the process- ing of health data apply to the grounds for the lawfulness of processing, transparency, and security measures. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices Products are classified through the definition of medicine (function and/or presentation) and the definition of medical device provided in the applicable legal provisions. In the case of bor- derline products, the purpose intended by the manufacturer of the product in question and the mechanism through which the main desired effect is achieved is considered. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Medicines developed by means of one of the fol- lowing biotechnological processes must be sub- jected to the centralised community procedure: • recombinant DNA technology; • controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes, including transformed mamma- lian cells; and
• hybridoma and monoclonal antibody meth- ods. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Medicines In the case of medicines, the MA is valid for five years; after the first renewal, it is valid indefinitely or, if considered necessary, for a second five- year period. The renewal of the MA is subject to a specific renewal procedure. An MA may be revoked, suspended or amended whenever there is non-compliance with the appli- cable legal and regulatory provisions or with the conditions of the MA in question. This includes when it is concluded that the risk-benefit bal- ance is unfavourable, the medicine is harmful or the manufacturing process does not comply with the applicable good practices. Medical Devices No authorisation is required to place medi- cal devices on the market. The manufacturer must submit the medical device to a conformity assessment and notify the competent authority that the medical device has been made available on the market. INFARMED may withdraw a prod- uct from the market or may suspend, restrict or subject to certain conditions the placing on the market and putting into service of a device or group of medical devices under certain condi- tions – namely when the use of medical devic- es could compromise the health and safety of patients or other persons, or for public health reasons.
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