The compliance monitoring is conducted by the Agency via pharmaceutical inspectors. Pharmaceutical wholesalers with turnover above MKD 10,000,000 or approx. EUR 162,602 are subject to mandatory inspection conducted by two pharmaceutical inspectors, two tax inspectors and one custom official.
If the advertising is unlawful, the pharmaceutical inspectors are entitled to forbid it and to order destruction on all materials used for that purpose.
A fine in the amount of EUR 50,000 will be imposed on the legal entity, if it:
- Advertises prescription-only Medical Products to the general public;
- Prescribes false characteristics, highlights its positive effects, uses improper manner in describing its effects, compares Medical Products with other ones or uses any other manner that is misleading for the consumer,
- Advertises by addressing children;
- Distributes free samples to the general public;
- Advertises Medical Products without marketing authorisation; or
- Advertises Medical Products used only in healthcare institutions.
A fine in the amount of 30% thereof will be imposed on the responsible person within the legal entity, whilst the responsible employee will be fined a sum of EUR 5,000 up to EUR 7,500.
A fine in the amount of EUR 30,000 will be imposed on the legal entity, if it:
- Violates the statutory general rules for advertising Medical Products to healthcare professionals;
- Promotes Medical Products by exceeding the scientific-expert purposes; or
- Misinforms the general public on Medicine Product’s characteristics.
A fine in the amount of 30% thereof will be imposed on the responsible person within the legal entity, whilst the responsible employee will be fined a sum of EUR 3,000 up to EUR 4,500.