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 main article: drug policy of 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 for misuse and therapeutic effectiveness. cd1: cannabis, lysergamide, coca leaf, etc. use is prohibited except in limited circumstances where a license has been granted. cd2: amphetamine, methadone, morphine, fentanyl, oxycodone, tapentadol, etc. prescriptions must be handwritten and are only valid for 14 days. repeat prescriptions are not permitted. drugs must comply with safe custody and destruction of unsold/unused medication must be witnessed. must be registered in a controlled drugs register. cd3: temazepam, flunitrazepam, etc. as cd2, except witnessed destruction and cd register are not required. cd4: benzodiazepines, e.g. diazepam, nitrazepam, low dose (methyl)phenobarbitone cd5: low-dose codeine, etc. myanmar (burma) the regulation of drugs in burma is governed by the food and drug administration (burma) and food and drug board of authority. norway medicines in norway are divided into five groups: class a narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form: morphine and its immediate family, heroin, desomorphine, nicomorphine; codeine and its immediate family, dihydrocodeine, ethylmorphine, nicocodeine; morphine relatives: hydromorphone and oxymorphone; codeine relatives: hydrocodone and oxycodone; synthetic opioids: pethidine, methadone, fentanyl, and levorphanol; various sedative-hypnotics: temazepam, methaqualone, pentobarbital, and secobarbital; various stimulants: amphetamines and methylphenidate; flunitrazepam (moved from class b) class b restricted substances which easily lead to addiction like: co-codamol tramadol diazepam nitrazepam all other benzodiazepines (with the exception of temazepam and flunitrazepam) phentermine class c - all prescription-only substances class f - substances and package-sizes not requiring a prescription unclassifieds - brands and packages not actively marketed in norway philippines the food and drug administration regulates drugs and medical devices in the philippines. sri lanka prohibited. brands and packages not actively marketed in sri lanka. switzerland medicines in switzerland are regulated by swissmedic. the country is not part of the european union, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds. there are five categories from a to e to cover different types of delivery category: a: supply once with a prescription from a doctor or veterinarian b: supply with a prescription from a doctor or veterinarian c: supply on technical advice from medical staff d: supply on technical advice e: supply without technical advice united kingdom medicines for human use in the united kingdom are regulated by the medicines and healthcare products regulatory agency (mhra). the availability of drugs is regulated by classification by the mhra as part of marketing authorisation of a product. the united kingdom has a three-tiered classification system: general sale list (gsl) pharmacy medicines (p) prescription only medicines (pom) within pom, certain agents with a high abuse/addiction liability are also separately scheduled under the misuse of drugs act 1971 (amended with the misuse of drugs regulations 2001); and are commonly known as controlled drugs (cd). united states therapeutic goods in the united states are regulated by the u.s. food and drug administration (fda), which makes some drugs available over the counter (otc) at retail outlets and others by prescription only. the prescription or possession of some substances is controlled or prohibited by the controlled substances act, under the fda and the drug enforcement administration (dea). some us states apply more stringent limits on the prescription of certain controlled substances c-v and btc (behind the counter) drugs such as pseudoephedrine. three primary branches of pharmacovigilance in the u.s. include the fda, the pharmaceutical manufacturers, and the academic/non-profit organizations (such as radar and public citizen).