Legal alert no. 100

It was published in the Official Gazette of the Republic of Portugal, Decree-Law 112/2019, dated from 16th August, which amends the legal regime of medicines for human use.

This Decree-Law aims to improve citizens' access to medicines and effectively respond to the shortage of medicines in the national market. To this end, the supply of medicines is amended, the procedures and responsibilities for the medicine’s unavailability are clarified and the involvement of all players of the circulation of medicines is reinforced.

The entities authorized to perform the wholesale distribution of medicines are provided with 180 days to request to INFARMED the update of the relevant authorizations or registrations.

This Decree-Law enters into force on August 17th, 2019.

To access the complete provisions of the Decree-Law, please click here.

For further information or clarification of any aspect of our Legal Alert, please do not hesitate to contact CTSU - Law Firm, Member of Deloitte Legal network.

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