1. IMPACT Regional Conference on Combacting Counterfeit Medical Products 9-10 November 2009 Kempton Park – South Africa Mozambique Experience

2. Mozambique

4. Definition of counterfeit medical product A counterfeit product is a product bearing a mark that is "identical with or substantially indistinguishable from" a genuine trademark; Doesnt follow the quality, safety and efficacy requisites for a medical product; Dangerous for the Public Health Crime Mozambique

5. Our National Legislation None specific legislation about counterfeit medicines or medical products Law 4/98 from 14th January - Medicines Law – it legislates the manufacture, importation, comerce and dispense of medicines and ensures that the medicines that arrive to the population have quality, safety and eficacy and correspond to the needs of the population. Mozambique

6. Decrete 21/99 from 4th May – Regulates the Farmacist conduct in his act – Defines the conditions, rules and the procedures for the exercise of the farmaceutical practice, in form to assure the tecnical, ectical, moral and deontologic principals Decrete 22/99 from 4th May – Regulates de registration of medicines Penal Code of Mozambique Our National Legislation Mozambique

7. Penalties Law 4/98, Cap. VII, Secção II, Art. 45: 1. Constitute, in the terms of the Law, a breach of the Law that can be punished with the fine between 80.000,00Mt and 200.000,00Mt: c. The robbery and the ilicit sale of medicines; d. The manufacture, importation, exportation and distribution of medicines without the respective quality control– without the comprovative of quality; e. The comerce or distribution of alterados ou adulterados medicines; f. The falsification of laboratorial and quality control certificates of medicines. Mozambique

8. Penalties Penal Code Art. 216 – Falsification of documents (includes certificates of quality) – 2 to 8 years of prison Art. 222 – Using false documents – The same as the autor (2 to 8 years) Mozambique

9. Penalties Penal Code Art. 228 – Falsification of stamps or trademaks – 2 to 8 years of prison Art. 248 – Crimes against Public Health – Selling or exposing poisoning or abortive substances – Not less 3 months of prison and a tax/fine Art. 249 – Crimes against Public Health – Substitute or change a perscription giving a deteriorated medicine. – Not less 1 months of prison and a tax/fine Mozambique

10. Number of cases Unknown Mozambique

11. Our proposal of action Create or adopt a regional specific legislation about counterfeit medical products; Create a specific unit inside the Inspective body of the MRA; Establish cooperation with Customs and Police Create a cooperation with the private sector to promote the fight against counterfeit products; Mozambique

12. Our proposal of action Create cooperation with industries; Create a cooperation with OMS, Interpol and Impact to receive information and participate in debates about this matter, acknowledging the experience of other countries; Receive training on detecting and investigating counterfeit medicines; Educate the population where to buy the medicines Mozambique

13. Thank you Obrigado Mozambique