IMPACT Regional Conference on Combacting Counterfeit Medical Products

1. IMPACT Regional ConferenceonCombactingCounterfeitMedicalProducts MozambiqueExperience 9-10 November 2009 KemptonPark – SouthAfrica

2. Mozambique

4. Definitionofcounterfeitmedicalproduct • A counterfeit product is a product bearing a mark that is "identical with or substantially indistinguishable from" a genuine trademark; • Doesn’t 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. Our National Legislation • 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 Mozambique

7. Penalties • Law 4/98, Cap. VII, Secção II, Art. 45: 1. Constitute, inthetermsoftheLaw, a breachoftheLawthatcanbepunishedwiththe fine between 80.000,00Mt and 200.000,00Mt: c. Therobberyandtheilicitsaleofmedicines; d. The manufacture, importation, exportationanddistributionofmedicineswithouttherespectivequalitycontrol–withoutthecomprovativeofquality; e. Thecomerceordistributionofalterados ou adulterados medicines; f. Thefalsificationof laboratorial andqualitycontrolcertificatesofmedicines. 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 – Falsificationofstampsortrademaks • 2 to 8 yearsofprison • Art. 248 – Crimes againstPublicHealth – Sellingorexposingpoisoningorabortivesubstances • Notless 3 monthsofprisonand a tax/fine • Art. 249 – Crimes againstPublicHealth – Substituteorchange a perscriptiongiving a deterioratedmedicine. • Notless 1 monthsofprisonand 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. Thankyou Obrigado Mozambique