PhaRegistrum · Originally published on 05/05/2026
Under Article 162 of Portuguese Decree-Law No. 176/2006 (Medicines Statute), sample distribution is subject to strict requirements:
- Samples may be supplied only to healthcare professionals authorised to prescribe.
- They must not exceed the smallest marketed pack size.
- A maximum of four units per medicine per professional per year.
- Distribution is permitted only during the two years following the start of marketing.
Although a legitimate tool, sample distribution is highly regulated.
A specialist partner such as PhaRegistrum helps ensure compliance and avoid administrative offence risks.
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