PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices The marketing of a medicine may follow one of these procedures: • a national procedure, if the medicine is intended to be approved only for placing on the Portuguese market; • a mutual recognition procedure, in which an authorisation obtained in a member state is used to apply for authorisation in a new member state; • a decentralised procedure, when the applica- tion is submitted in several member states simultaneously and when the medicine does not have an MA in any member state; and • a centralised procedure, managed by the European Medicines Agency (EMA), leading to an MA that is valid in all member states. Any change in the terms of an MA must be sub- ject to an application for a variation of the MA, including changes to the summary of product characteristics and any conditions, obligations or restrictions affecting the MA or changes to the labelling or package leaflet in connection with changes to the summary of product character- istics. An MA may be transferred to a new holder by submitting a transfer application by the MA holder. The placement of a medical device on the mar- ket does not require authorisation (see 3.3 Peri- od of Validity for Marketing Authorisation for Pharmaceutical or Medical Devices ).
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Medicines without an MA or without an MA that is valid in Portugal may be made available to patients through the exceptional use authori- sation, under which patients can access them through early access programmes, which have a specific regulation issued by INFARMED. Regarding medical devices, INFARMED may authorise the placing on the market or putting into service of a medical device for which no conformity assessment procedures have been carried out but the use of which is in the interest of public health or patient safety or health. Compassionate use also takes place in the con- text of clinical trials. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations The MA for a medicine may be granted subject to the subsequent conduct of additional studies or compliance with special rules regarding safety and the reporting of all incidents associated with the use of the medicine and the measures to be taken, the conduct of a post-authorisation safety or efficacy study, or the fulfilment of other obliga- tions established by INFARMED. After the granting of an MA, INFARMED may require its holder to conduct a post-authorisation safety study if there are doubts about the risks of the authorised medicine or if knowledge about the disease or clinical methodology indicates that previous efficacy evaluations may need to be significantly revised. The holder of an MA is obliged to comply with the obligations provided for by law – namely,
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