One of the most important aspects of the fundamental right of access to healthcare is the continuous and appropriate supply of medicinal products to patients. In this respect, all parties involved in the pharmaceutical supply chain have responsibilities in the availability of medicines to citizens as part of their public service obligations.
The availability of medicines has been a central subject to the World Health Organisation and the European authorities. Accordingly, the HMA/EMA Task Force on Availability of authorised medicines for human and veterinary use (TF AAM) has been created, with INFARMED as part of the coordinating structure.
Infarmed is also part of the European network of single point of contact network (SPOC) between national authorities of Member States and the European Medicines Agency (EMA), which since April 2019, has been used to share information on shortages and on availability issues of medicinal products authorized in the European Union.
At Infarmed, the management of the availability of medicinal products is guaranteed by a dedicated unit - Unit for Interinstitutional and Health System Projects (USS) -, which liaises with all the key stakeholders and, in a collaborative manner, discusses each situation and solutions or mitigation measures.
For this purpose, it is essential the collaboration with the National Commission of Pharmacy and Therapeutics.
For further details, read the Availability Management brochure.
The notification of sporadic short-term unavailabilities of more than 12 hours of marketed presentations is submitted by pharmacies and wholesalers through a dedicated web service. The access and instructions to the webservice can be requested by email (firstname.lastname@example.org).
Healthcare professionals, citizens and patient advocacy groups can also notify these unavailabilities through email - email@example.com - by stating the brand name, strength, pharmaceutical formulation and registry number.
The temporary unavailability, either likely or confirmed, of a marketed presentation must be submitted by marketing authorisation holders 2 months in advance, through the platform SiATS.
The permanent unavailability of a marketed presentation must be notified by market authorisation holders 2 months in advance, through the platform SiATS.
In order to mitigate out-of-stock situations and to guarantee access to the medicines that patients need, Infarmed can authorise the marketing authorisation holder (MAH), or its representative, the exceptional use and import of medicines’ batch(es).
The requests must be submitted by e-mail to firstname.lastname@example.org with the following elements:
- Application form;
- Batch certificate of analysis;
- Marketing Authorisation Certificate in the country of origin;
- Summary of Product Characteristics (SPC) and Package Leaflet (PL) approved in the country of origin.
Marketing authorisation for medicines without valid authorisation or registration in Portugal (SAR)
For public health reasons, Infarmed can grant a marketing authorisation for medicines without a valid authorisation or registration in Portugal (SAR).
The request must be sent by email to email@example.com with all the elements foreseen in Chapter V of the Deliberation no. 1546/2015, of June 18, which are detailed in the submission form.
Shortages, unavailabilities and cessations of commercialization are monitored on a daily basis, in order to identify and avoid critical situations that may affect the availability of medicines.
Within the scope of availability control, one of the measures adopted to ensure a balance between the regular supply of the market and the export of medicines is the compliance with the Regulation on ex-ante notification system on transactions of medicinal products.
Ex-ante notification list (LNP)
The list of medicines which export or distribution to other EU Member States requires ex-ante notification to Infarmed is updated quarterly. This list is based on a set of criteria, namely:
- Percentage of consumption satisfied;
- Percentage of prescription satisfied;
- Number of reported unavailabilities;
- Relationship between exports / reported unavailabilities.
- Number of available medicines with the same CNPEM;
- Critical INN (based on the list of substances whose accessibility is considered essential);
- Narrow therapeutic margin (based on the list of active substances with a narrow therapeutic index or margin).
The notification is made on the SiExp platform by:
- MAH holders the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of every month;
- Distributors and Intermediaries:
- the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of every month;
- the intention of exporting or distributing to other Member States medicines listed in the ex-ante notification list, 5 to 20 days before the transaction.
- Pharmacies - the quantities of medicinal products included in the ex-ante notification list supplied monthly until the 15th of each month.
List of medicinal products which exports are temporarily suspended
The list of medicinal products which exports are temporarily suspended includes effective shortages of high and medium impact in public health registered in the previous month and medicinal products supplied under exceptional authorisations.
This list is updated monthly and is intended to ensure the adequate market supply.