and regulations. Amongst these rules and regulations are: Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts Directive 93/41/EEC, establishes the European Agency for the Evaluation of Medicinal Products Directive 2001/20/EC, defines rules for the conduct of clinical trials Directive 2001/83/EC Directive 2005/28/EC, defines Good Clinical Practice for design and conduct of clinical trials Germany German law classifies drugs into Narcotics ("Betäubungsmittel") Anlage I BTMG (authorized scientific use only) Anlage II BTMG (authorized trade only, not prescriptible) Anlage III BTMG (special prescription form required – "Betäubungsmittelrezept") Research chemicals ("neue psychoaktive Stoffe" – permitted only for industrial and scientific purposes) Prescription drugs ("verschreibungspflichtig" or "rezeptpflichtig") Pharmacy-only drugs ("apothekenpflichtig") General sales list drugs ("freiverkäuflich") Raw materials for synthesizing drugs Kategorie 1 (authorization required) Kategorie 2 (reporting required) Kategorie 3 (export restrictions) Iceland Medicines in Iceland are regulated by the Icelandic Medicines Control Agency. India Medicines in India are regulated by Central Drugs Standard Control Organization (CDSCO) Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services, CDSCO regulates pharmaceutical products through Drugs Controller General of India (DCGI) at chair. Drugs are classified under five headings. Under retail and distribution: Schedule X drugs - narcotics Schedule H and L - injectables, antibiotics, antibacterials Schedule C and C1 - biological products, for example serums and vaccines Under manufacturing practice: Schedule N - list of the equipment for the efficient running of manufacturing wing, qualified personnel Schedule M Indonesia Medicines in Indonesia are regulated by National Agency of Drug and Food Control of Indonesia. Drugs in Indonesia are classified into: Over-the-counter (OTC) drug (Obat bebas), drugs freely available to the public. Marked by green circle with black line. Limited OTC drug (Obat bebas terbatas), drugs available to the public only through pharmacy (apotek) or licensed drug stores. Marked by blue circle with black line. Prescription drug (Obat keras), prescription only medicine. Marked by red circle with letter "K" inside circle and black line. Narcotics and psychoactive drugs (Obat psikotropika dan narkotika). National Narcotics Board perform law enforcement measure at illegal drug abuse and drug trafficking. Ireland Medicines in the Ireland are regulated according to the Misuse of Drugs Regulations 1988. Controlled drugs (CDs) are divided into five categories based on their potential