PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
2.5 Use of Data From Clinical Trials Data from clinical trials of medicines and clinical stud- ies of medical devices may qualify as sensitive per- sonal data. However, if the data is fully anonymised (and not merely pseudonymised), it is no longer per- sonal data and therefore does not fall within the cate- gory of sensitive data. Anonymisation implies that the data subject’s identity is unobtainable, which makes the data anonymous. If the data resulting from processing is still classified as personal data, it may be shared with third par- ties or affiliates. However, this transfer must adhere to the requirements of the General Data Protection Regulation (GDPR). This includes obtaining consent, fulfilling information obligations, ensuring the secu- rity of the processing, establishing joint controllership or sub-processing agreements, and complying with regulations regarding international data transfers. If the resulting data is anonymised, then those GDPR requirements do not apply. 2.6 Personal or Sensitive Data The GDPR requirements regarding the processing of health data apply to the grounds for lawfulness, trans- parency and security measures. Products are classified through the definition of medi- cine (function and/or presentation) and the definition of medical device provided in the applicable legal pro- visions. In the case of borderline products, the pur- pose intended by the manufacturer of the product in question and the mechanism through which the main desired effect is achieved are considered. Regarding other borderline situations (medicines and cosmetics, or medicines and food supplements), the function and/or presentation are also considered. 3.2 Marketing Authorisation for Biologic Medicinal Products Medicines developed by means of one of the following biotechnological processes must be subjected to the centralised community procedure: 3. Marketing Authorisations 3.1 Product Classification
• recombinant DNA technology. • controlled expression of genes coding for biologi- cally active proteins in prokaryotes and eukaryotes, including transformed mammalian cells. • hybridoma and monoclonal antibody methods. The following medicines are also subject to central- ised procedures: • advanced therapy medicinal products; and • medicinal products for human use containing a new active substance for which the therapeutic indication is the treatment of any of the following diseases: AIDS, cancer, neurodegenerative dis- order, diabetes, autoimmune diseases and other For medicines, the MA is valid for five years; after the first renewal, it is valid indefinitely or, if deemed neces- sary, for a second five-year period. The renewal of the MA is subject to a specific renewal procedure. MA may be revoked, suspended or amended when- ever there is non-compliance with the applicable legal and regulatory provisions or with the conditions of the MA in question. This includes when it is concluded that the risk-benefit balance is unfavourable, the med- icine is harmful or the manufacturing process does not comply with the applicable good practices. Medical Devices No authorisation is required to place medical 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 product 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 conditions – namely when the use of medical devices could com- promise the health and safety of patients or other persons, or for public health reasons. immune dysfunctions and viral diseases. 3.3 Period of Validity of Marketing Authorisations Medicines
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