The transposition of Directive 2011/62/EU in Portugal
Following the developments in the European Union law, in particular on medical products counterfeiting and pharmacovigilance,introduced by the publication of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, it became necessary to amend the Portuguese legislation, in order to introduce in the national legal framework the measures laid down in the Directive, which happened with the publication of the Decree-Law n. 128/2013 of 5 September.
Through theDecree-Law 128/2013, Portugalproceeded to amend theDecree-Law n. 176/2006 of 30 August, with regard to pharmacovigilance issues,brokering of medicinal productsand protection againstthe risks related to falsified medicinal products’ entry into the European Union. In detail:
- it was given a definition offalsified medicinal product
- it was defined and regulated thebrokering of medicinal products
- it became mandatory to notify to INFARMED, IP if any suspicion on falsifiedmedicinal productsarise, either in the legal or illegal supply chain;
- medical devices were regulated
- it was created a prevention system to avoid that a suspicious medicine reaches patients (the system includes the medicinal products’recall in case of counterfeiting)
The sale at a distanceof medicinal products to the public by pharmacies and over-the-counter (OTC) stores was introduced by the aforementioned Decree-Law128/2013 into the Decree-Law 307/2007 of 31 August, which now foresees this possibility in the article 9ºA.The Decree-Law 307/2007 allows the selling of medicinesby pharmacies and OTC stores, either in their facilities or domicile deliveries. INFARMED, IP licenses all Portuguese pharmacies and registers all OTC stores.
A request ofmedicinal productscan be sent to the pharmacy or OTC store by any communication means, including the electronic web page of each facility.The delivery of the medicinal product athome, regulated by Decree No. 1427/2007, of 2 November, requires a previous communication to INFARMED, IP, and it is limited to the municipality and neighboring municipalities where the pharmacy is located.Consequently, in Portugal, the sale of prescription medicinal products is limited to the pharmacy municipality and the neighboring municipalities, which is justified by the pharmacies installation’sexisting rules.
The novelty introduced by the Directive 2011/62/EU, dealing also with the sell at a distance of medicinal products, was to give the possibility to pharmacies and OTC stores to sell medicinal products to patients from other Member States (MS) of the EU.National legislation, on this subject, proceeded to almost full transposition without innovations of the provisions of the Directive 2011/62/EU.
Medicines can be sold online, only if dispensed by an authorized pharmacy or OTC store registered in Infarmed IP.
The pharmacy / OTC store must notify toINFARMED, IP the following:
- the starting date of the delivery activity of medicinal productsto a private domicile
- the address of the website
- the classification of medicinal products(if applicable) (prescription or non-prescription ones)
The pharmacy/OTC store should comply with the legislation of the MS of destination, particularly on the existence of marketing authorization.
The e- pharmacy web siteshall include:
- thereferencesof INFARMED, IP
- the link to the website of INFARMED, IP
- thecommon logo.
INFARMED, I.P. shall make available on its website the following:
- information on legislation and possible differences in legislation between Member States
- information on the common logo (goals and objectives)
- Information on the risks associated with the sale of medicinal products by illegal sites
- the link to the European Medicines Agency (EMA) web site
- a list of all entities able to sell medicines at a distance
Legal websites selling medicinal productsshalldisplay in each web page the common logo that helps users to recognize them as legitimate websites, linked to an entity duly qualified to provide medicinal products. It is a visual aid that allowsto distinguish licensed websites from unauthorized ones.
For more information:
Law 176/2006 of 30 August
Decree-Law 307/2007, in its current wording
Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011