Pharma 2020 Bahrain
1. What are the main laws governing the manufacture and sale of pharmaceuticals in Bahrain?
Bahrain Decree-Law No. 18/1997 with Respect to the Practice of Pharmacists and Pharmaceutical Centres (as amended by Bahrain Decree-Law No. 20/2015) (the Law).
2. Are there any significant differences in this area of law in this jurisdiction compared to jurisdictions like the US and EU?
Bahrain Decree-Law No. 18/1997 specifies a license for opening a pharmaceutical centre will only be given for licensed Bahraini pharmacist who is at least 21 years or a company where more than one pharmacist owns at least 50% of the company shares.
Bahrain Decree-Law No. 18/1997 also lays limits the number of pharmacies. No natural or legal person or a partner in a company may be licensed to open more than five pharmacies. This number may be exceeded by one pharmacy in any area of more than five square kilometres without an existing pharmacy, so long as a decision has been issued by the Board of Directors.
3. Who are the main regulators governing the licensing, the sale, or the manufacture of pharmaceuticals in Bahrain?
The National Health Regulatory Authority (the NHRA) is responsible for regulating healthcare in Bahrain.
4. When new drugs are created, which agency is responsible for giving the permission for the sale/manufacture in this jurisdiction?
The National Health Regulatory Authority (the NHRA).
5. What steps must a pharmacist take before being allowed to practice in this jurisdiction?
A Licensed Pharmacist is defined in Bahrain Decree-Law No. 18/1997 as a pharmacist licensed to practice the pharmacy profession in line with the Law. Anyone who wants to obtain a license to practice the pharmacy profession must submit an application on the application form intended for this purpose to the NHRA. Under Bahrain Decree-Law No. 18/1997, the requirements needed to obtain a license to practice are as follows:
- To be a Bahraini national, and the Board of Directors may exempt them from this requirement if there are justifiable reasons.
- Must hold a bachelor's degree in pharmacy or equivalent from an accredited programme.
- Any document certifying the applicant's success in local concessions or interviews organised by a special committeeestablished for this purpose.
- A Certificate proving that no criminal judgments have been issued against an applicant which prejudices their integrity or honour unless they have been forgiven by the relevant authorities.
The licensing standards are set by the NHRA. They also specify the educational qualifications and professional experience required for Bahraini nationals and non-Bahraini residents living in Bahrain.
6. What are the requirements involving ownership and licensing of a pharmacy in Bahrain?
Pharmaceutical Centres are defined in Bahrain Decree-Law No. 18/1997 as all type of public pharmacies, their branches and private pharmacies. A pharmaceutical centre may not be opened without obtaining a license from the NHRA first. A license for opening a pharmaceutical centre will only be given for licensed Bahraini pharmacist who are at least 21 or a company where more than one pharmacist owns at least 50% of the company's shares. If the owner dies, the pharmacy will be managed by a pharmacist for the benefit of the heirs.
7. What rules govern the dispensing of prescription of drugs in Bahrain?
Under Bahrain Decree-Law No. 18/1997, the controlled drugs may only be dispensed by a licensed pharmacist and a register must be kept of all amounts received, dispensed, the date the drug was dispensed as well as the name of the doctor who issued the prescription. The prescription must be retained for one year. The prescription must be written in clear handwriting for the pharmacist to prepare the medicine or pharmaceutical product listed without any confusion or ambiguity. The pharmacist may not replace the medicine or pharmaceutical product prescribed in the prescription with another drug. In addition, the pharmacist may, with the consent of the patient, dispense a drug similar to that prescribed in the prescription if the drug contains the same active ingredient and the same concentration in the prescribed medicine, provided the physician did not document otherwise.
The pharmacist must refrain from dispensing a product or pharmaceutical product if they suspect an error in the prescription and must consult the relevant physician. The pharmacist does not have permission to make any changes to the medications or pharmaceutical products recorded in the prescription with respect to the quantity, type or method of use, without prior written consent from the relevant physician.
8. Are there rules on the pricing on prescription drugs in Bahrain?
All pharmacies must have an updated registry recording all medications prepared on a daily basis indicating, among other things, the price along with the relevant pharmacist signature.
The official price of all pharmaceutical products must be declared and must be shown on the package. The pharmacies should keep a list of all the prices set by the NHRA.
Any one who sells drugs or pharmaceutical products or health products at a price exceeding the official price set by the NHRA will be guilty of an offence. They will be jailed for one month and/or fined up to 300 Dinars.
9. What rules apply when importing controlled substances and prescription drugs into Bahrain?
With the exception of pharmaceutical facilities, drugs and pharmaceutical products, including any free medical samples, may not be imported except through the pharmacy centres and subject to obtaining a license from the NHRA, in line with the conditions and procedures determined by a decision of the Board of Directors.
Drugs and pharmaceutical products cannot be imported for personal use, whether in parcels or other packages, unless the conditions specified by a decision of the Board of Directors are met.
The import of controlled drugs is subject to the following conditions:
- The importer must submit a request specifying the types and quantities of drugs to be imported after reviewing the products records at the relevant section of the NHRA.
- The approval for the import of the product complies with the accredited procedure set by international organizations.
10. What are the penalties for contravention of these import rules?
Anyone who imports medicines and/or pharmaceutical products in violation of Bahrain Decree-Law No. 18/1997 has the right to re-export the quantity within one month of the date the product is delivered at their own expense.
The offence of violating the importing provision of Bahrain Decree-Law No. 18/1997 will lead to a fine of 200 Dinars.
Bahrain Decree-Law No. 18/1997 prohibits the importing of drugs and pharmaceutical products for personal use. Those who violate this provision will be fined up to 100 Dinars. These fines will be accompanied confiscating all of the drugs and pharmaceutical products or health products for which offences were committed. The importer of the product will have no right to demand compensation.
11. Do rules on import of controlled substances and prescription drugs come into play when drugs are brought into the country having been purchased overseas on the internet or having been brought into the country in transit?
12. What are the main laws protecting intellectual property in the pharmaceutical industry? Are there any significant allowances in the way things work compared to jurisdictions such as the US and EU?
Bahrain is a contracting state to the Patent Cooperation Treaty (PCT) which came into force in the Kingdom on 18 March 2007. The nationals and residents of Bahrain are themselves able to file PCT applications.
The Gulf Cooperation Council Patent Office (GCCPO) offers a convenient alternative to filing separate applications in the GCC without the need for further validation in each country or payment of separate annuities.
Patents are also protected in Bahrain under Bahrain Law No. 1/2004 on Patents and Utility Models (as amended by Bahrain Law No. 14/2006).
13. Are health supplements, vitamins or other non-prescription drugs regulated in any particular way?
According to Bahrain Decree No. 9/2016 in relation to Classifying Pharmaceutical Products and Health Products, a pharmaceutical product is classified as a health product or medicine, based on the Pharmaceutical Product Classification Guideline annexure to the Decree (PPC Guidelines). The health products include herbal products, products containing vitamins or minerals and other products containing specific substances like amino acids, charcoal lipids like Omega 3 and certain antiseptics.
Before a pharmaceutical product can be sold in Bahrain, an application must be made to the NHRA and this must contain all of the necessary data supporting its quality, safety and efficacy, based on the current guidelines and procedures. PPR members review the scientific aspects of each application and reach a conclusion on the likely balance of any benefits versus risk before arriving at a decision.
14. Are there any significant rules on the packaging of drugs in Bahrain?
The official price of all pharmaceutical products must be declared and must be shown on the package in line with Bahrain Decree-Law No. 18/1997 and NHRA rules and regulations. The leaflet of each pharmaceutical drug must have the following information in both Arabic and English:
- List of the active components and the scientific name of each component.
- The quantities of active components in line with the required doses or regimen.
- List components which may interfere or affect the use of the medicine or pharmaceutical product.
- The internationally accredited therapeutic uses of the product.
- The forms of drug doses.
- The side effects and major adverse reactions of the product or pharmaceutical product.
- Required precautionary measures, prohibitions and taboos.
- Main interactions.
- The product name and address.
- A list of the scientific references used.
15. Are those involved in virtual medicine allowed to prescribe or sell drugs to patients?
Yes, telemedicine is legally permitted in Bahrain in line with NHRA standards.
16. Are there any rules governing the advertising of drugs?
The text and illustrations in the advertisements directed at doctors and health professionals must be in line with approved scientific data and must be clear and unequivocal or unambiguous. It is completely prohibited to advertise prescription drugs. To advertise non-prescription drugs, written consent from the NHRA is required. The pharmaceutical product advertisements must be consistent with the declared contents of the product and should not contain expressions contrary to public morals or which would mislead the public. No person may be engaged in the promotion of pharmaceutical product unless licensed by the State after paying the licensing fees. Those to be licensed to practice this profession must have a university degree or diploma from a credited college or institute. Drug specimens intended for advertising cannot be traded or offered for sale. These specimens must be labelled Free medical samples clearly in Arabic and English. The doctors may be provided with free samples of drugs when requested. However, it is prohibited to promote free samples to the public.
17. What is the main legislation governing legal possession of controlled substances?
Bahrain Law No. 15/2007 with respect to Narcotic Drugs and Psychotropic Substances.
18. Are laboratories carrying out research with drugs required to be registered? If so, who is the regulator and what are the main steps?
A pharmaceutical manufacturing factory will contain the necessary requirements to function and in particular, the following sections:
- Production: containing the necessary machinery and equipment specified by the Ministry.
- Drug Control section: includes three parts:
- The chemical laboratory equipped with raw substances and technical equipment for analysis during the
- production process.
- Sterilisation laboratory equipped with modern technical equipment for the sterilisation of produced drugs.
- Microbiology laboratory equipped with appropriate devices to measure the rate or the presence of bacteria and fungi etc.
19. Are there any specific health and safety rules governing the operation of laboratories handling dangerous materials and disposal of waste substances?
The Waste Management Department at the Supreme Council for the Environment will study the waste disposal request scientifically and accordingly accurately determine the best way to dispose of the waste.
20. Are there any specific rules governing testing of pharmaceuticals on humans or animals?
The NHRA has established clinical trials or regulatory research requirements which define the conditions under which clinical trials or research will be conducted in Bahrain. The regulatory requirements also apply to all healthcare facilities and providers, clinicians-investigators, academic centers, sponsors and third parties participating in the clinical trials or research. All research involving human beings will be reviewed by an Institutional Independent Research Ethics Committee (IREC) to ensure the appropriate ethical standards. IREC's standards and requirements are based on international regulations and standards on Good Clinical Practice, provided by leading regulatory bodies like the World Health Organization, US Food & Drug Administration, European Medicines Agency and International Conference of Technical Requirements for the Registration of Pharmaceuticals for Human Use.
The trial subject can be any of the following:
- A healthy volunteer;
- A patient whose disease is not related to the administration of the trial product; or
- A patient whose disease is related to the use of the trial product.
21. Do rules on dispensing drugs to animals differ from those in dispensing to humans?
A licensee authorized to practice the profession will not combine the practice of pharmacy and medicine or dentistry or veterinary medicine, even if they hold the required qualifications. However, the licensee is not in violation of the practice of medicine while practising First Aid in cases of emergency or accidents in the pharmacy premises. However, the licensee must refrain from prescribing medication or other conditions in violation of the law for practising medicine.
22. Do the rules on practicing as a pharmacist or selling drugs differ in the free zones?
23. Do the rules on manufacturing pharmaceutical products or pharmaceutical research differ in the free zones?
24. How do product safety and personal injury legislation operate in situations where a patient has been injured as a result of drug which was dispensed or manufactured in this jurisdiction?
The medical complaint unit of the NHRA is responsible for studying medical complaints and judicial assignments concerning the medical errors and the disciplinary accountability for the medical error or violation of the profession code of ethics or of the law of professional practice in Bahrain. The unit is also responsible for the study of adverse events reported to the NHRA by the healthcare providers and facilities. The unit deals with all complaints with the utmost confidentiality and gives equal consideration in line with the NHRA rules and regulations. Any complaints alleging error or negligence involving death or serious harm, and those which pose an immediate threat to public safety or health will be given priority.
25. Are there any drugs or therapies which are barred or have restrictions on their dispensing because of religious reasons?
As an Islamic country, Bahrain has a number of laws based around Quran teachings. It is forbidden for Muslims to consume alcohol, but non-Muslims in Bahrain may purchase alcohol from licensed stores. However, getting drunk in public will lead to detentions and fines. The use, possession, and trafficking of illegal drugs are strictly prohibited. These could lead to hefty fines, jail terms and even the death penalty.
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