PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Rúben do Carmo Pereira, PLMJ
3.4 Procedure for Obtaining a Marketing Authorisation 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 application is submitted in several Member States simultane- ously 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 valid in all member states. Any change in the terms of an MA must be subject to an application for a variation of the MA, including changes to the summary of product characteristics and any conditions, obligations or restrictions affect- ing the MA or changes to the labelling or package leaflet in connection with changes to the summary of product characteristics. An MA may be transferred to a new holder by submit- ting a transfer application by the current MA holder. The placement of a medical device on the market does not require authorisation (see 3.3 Period 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 with an MA that is valid in Portugal, may be made available to patients through the exceptional use authorisation, under which patients can access them and/or through early access programmes, which are subject to specific regulations issued by INFARMED. Regarding medical devices, INFARMED may author- ise the placing on the market or putting into service of a medical device for which no conformity assess- ment procedures have been carried out, but the use of
which is in the interest of public health, patient safety or health. Compassionate use also takes place in the context of clinical trials. 3.6 Ongoing Obligations Imposed by Marketing Authorisations The MA for a medicine may be granted subject to the subsequent conduct of additional studies or com- pliance 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 con- duct of a post-authorisation safety or efficacy study, or the fulfilment of other obligations established by INFARMED. After granting 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 • knowledge of the disease or clinical methodology indicates that previous efficacy evaluations may need to be significantly revised. The holder of an MA is required to comply with the obligations provided for by law – namely, to comply with pharmacovigilance obligations and to make this or other data proving that the benefit-risk relation- ship of the medicine remains favourable available to INFARMED. Manufacturers of medical devices other than inves- tigational devices must report any field safety cor- rective action to INFARMED, as well as any serious incident or any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected to have undesirable side effects that could have a significant impact on the benefit-risk analysis and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations INFARMED publishes information on the status of an MA application and its assessment report on its web-
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