Buying MDMA pills Turkiye

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Buying MDMA pills Turkiye

These datasets underpin the analysis presented in the agency's work. Most data may be viewed interactively on screen and downloaded in Excel format. All countries. Topics A-Z. The content in this section is aimed at anyone involved in planning, implementing or making decisions about health and social responses. Best practice. We have developed a systemic approach that brings together the human networks, processes and scientific tools necessary for collecting, analysing and reporting on the many aspects of the European drugs phenomenon. Explore our wide range of publications, videos and infographics on the drugs problem and how Europe is responding to it. All publications. More events. More news. We are your source of drug-related expertise in Europe. We prepare and share independent, scientifically validated knowledge, alerts and recommendations. About the EUDA. MDMA is a synthetic drug chemically related to the amphetamines, but with somewhat different effects. In Europe, MDMA use has generally been associated with episodic patterns of consumption in the context of nightlife and entertainment settings. On this page, you can find the latest analysis of the drug situation for MDMA in Europe, including prevalence of use, seizures, price and purity and more. European Drug Report — home. The drug situation in Europe up to Drug supply, production and precursors. Synthetic stimulants. Heroin and other opioids. New psychoactive substances. Other drugs. Injecting drug use in Europe. Drug-related infectious diseases. Drug-induced deaths. Opioid agonist treatment. Harm reduction. Reported use of the drug appeared to decline temporarily during periods of social distancing during the early phases of the COVID pandemic. The currently available data would, however, suggest an overall relatively stable level of consumption but with national variations in the recent trends observed and the caveat that overall supply side indicators are suggestive of a slight recent decline in availability. About half of the European cities reporting wastewater analysis found an increase in MDMA residues between and , although in most other cities some decline was noted. Overall, available indicators suggest that MDMA production continues within Europe, both for domestic consumption and for export to non-EU markets. The information available is strongly suggestive that most MDMA production continues to be largely concentrated in or around the Netherlands. There are some signs of a reduction in the volume being manufactured in the most recent data. An important caveat here is that this information mostly covers the first years of the pandemic and needs to be interpreted with caution. In addition, while overall the average MDMA content of tablets and purity of powders remained stable in , a recent decrease in the MDMA content of ecstasy tablets was noted in some important source countries, most notably the Netherlands. With a typical MDMA content of to milligrams, the overall strength of tablets available on the retail marketplace still remains high by historical standards. It is difficult to interpret the more recent data with any certainty, but a possible decline in production volumes and some reductions noted in MDMA tablet content may indicate that producers have experienced greater problems sourcing precursor chemicals or that some producers may have switched to producing other substances, either because of market demand or because they are more profitable. It may also reflect a perceived consumer demand for lower-strength products. The use of MDMA is rarely cited as a reason for entering drug treatment in Europe but acute poisonings and deaths are sometimes associated with the consumption of this substance. The use of MDMA therefore continues to represent an important issue for prevention and harm reduction messaging and interventions. The availability of higher strength products potentially increases the risk of adverse health outcomes associated with the consumption of this substance. Interestingly, a decline in MDMA-related presentations by a quarter was observed in sentinel hospital emergency departments with data for and This data set, however, is difficult to interpret in respect to overall trends, as it is not nationally representative, has limited coverage and may reflect either changes in consumption or reporting during the pandemic. While it is again difficult to generalise due to limitations in national and European coverage, the available information from drug checking services suggests that MDMA products are generally less subject to adulteration than other illicit drugs they screened in This does occur however, as illustrated by the inclusion of synthetic cathinones in MDMA tablets observed on some occasions. These sorts of mixtures may also increase the risk to consumers of experiencing unexpected adverse effects and potential harm. This data explorer enables you to view our data on the prevalence of MDMA use by recall period and age range. You can access data by country by clicking on the map or selecting a country from the dropdown menu. Prevalence data presented here are based on general population surveys submitted to the EMCDDA by national focal points. For the latest data and detailed methodological information please see the Statistical Bulletin Prevalence of drug use. Graphics showing the most recent data for a country are based on studies carried out between and Mean daily amounts of MDMA in milligrams per population. Sampling was carried out over a week in March and April Show source tables. Back to list of tables. Homepage Quick links Quick links. GO Results hosted on duckduckgo. Main navigation Data Open related submenu Data. Latest data Prevalence of drug use Drug-induced deaths Infectious diseases Problem drug use Treatment demand Seizures of drugs Price, purity and potency. Drug use and prison Drug law offences Health and social responses Drug checking Hospital emergencies data Syringe residues data Wastewater analysis Data catalogue. Selected topics Alternatives to coercive sanctions Cannabis Cannabis policy Cocaine Darknet markets Drug checking Drug consumption facilities Drug markets Drug-related deaths Drug-related infectious diseases. Recently published Findings from a scoping literature…. Penalties at a glance. Frequently asked questions FAQ : drug…. FAQ: therapeutic use of psychedelic…. Viral hepatitis elimination barometer…. EU Drug Market: New psychoactive…. EU Drug Market: Drivers and facilitators. Statistical Bulletin home. Quick links Search news Subscribe newsletter for recent news Subscribe to news releases. This make take up to a minute. Once the PDF is ready it will appear in this tab. Sorry, the download of the PDF failed. Table of contents Search within the book. Search within the book Operator Any match. Exact term match only. No overall trend emerges from the data on MDMA use. Of the 11 European countries that undertook surveys since and provided confidence intervals, 1 reported higher estimates than their previous comparable survey, 9 reported stable estimates and 1 reported a decrease. Seizures of MDMA precursors increased to 2. The Netherlands, however, reported a lower average MDMA content of ecstasy tablets mg per tablet. MDMA market in Europe. Table 2. Prevalence of drug use in Europe, trends Country Country code Geographical scope Substance Recall period Age Austria AT National Table 3. Masaryk Water Resesrch institute, p. Table 4. Table 5. Table 6. Table 7. Table 8. Table 9. Table Main subject. Target audience. Publication type. European Drug Report main page. On this page. Forensic Toxicology Labs. Prevalence data presented here are based on general populaton surveys submitted to the EMCDDA by national focal points.

Distribution and Marketing of Drugs in Turkey

Buying MDMA pills Turkiye

There are very limited cookies on our website to protect your privacy during your visit experience. You can review our Cookie Policy to get detailed information about our cookies. What are the legal pre-conditions for a drug to be distributed within the jurisdiction? For placing the product on the market, the following additional regulations must be considered:. The principles for the inspections and examinations conducted by the Agency and the recall procedures for products posing threat to human health are also regulated in a variety of separate regulations. Although the regulations set out the obligation to have a licence in order to distribute drugs, there are alternative ways such as compassionate use or named patient use see Question 2. If so, what are the requirements for pre-launch access? The named patient use is defined as the special importation of drugs which have no marketing authorisation in Turkey or which have marketing authorisation but are not available in the Turkish market. This importation is based on the Guidelines on the Supply from Abroad of Drugs. This is an extendable list, therefore products can be added to this system on the approval of the Medicines and Medical Devices Agency Agency. Within the scope of these systems, products can be prescribed and imported without an actual licence. In addition, Turkey has a compassionate use programme established under the Guidelines on Compassionate Use Programme issued by the Agency Guidelines. This programme is defined in as an arrangement that aims to provide free of charge drugs which are not registered in Turkey and are registered or not registered in other countries, to patients whose treatment in Turkey has failed with the existing accessible products registered by the Agency and who suffer from a serious or urgent and life-threatening disease and have not been included in the scope of the clinical trials conducted in this field Article 1, Guidelines. In order for this program to be implemented, the treating physician of the patient must make a written commitment for taking over the responsibility of including the patient in this programme and report this to the Agency Article 2, Guidelines. Except for scientifically justifiable and very rare exceptional cases, drugs for which at least Phase II studies have been completed and Phase III studies have been initiated across the world, are included in the programme. The studies do not need to be conducted in Turkey for a product to be included in this programme. It is clearly stated that this programme is not a clinical trial and that the physician conducting the programme does not receive any payment under any name. This programme does not aim to collect information about the effectiveness of the drug and even if such information is collected, it will not be used in the procedures relating to the registration of the drug by the Agency. The Guideline explicitly states that compassionate use and off-label use cannot be conducted at the same time. What is the procedural structure regarding licensing a drug for distribution? The requirements set out in the Regulation on Licensing of Medicinal Products for Human Use Licensing Regulation must be met in order to be granted a licence and initiate the marketing of the drugs. The persons applying for a drug licence must meet the following conditions of eligibility:. The Agency evaluates the licence application in a day period. Article 15, Licensing Regulation However, in practice, this period can be extended even for a year or two, due to the workload of the Agency. The Good Manufacturing Practices GMP certificates required for the licensing are issued by the Agency after an on-site examination conducted by the Agency officials. This creates a lot of delays especially in the authorisation of imported products. Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction? An abridged application can be submitted. In abridged applications, the applicant is not required to present the results of toxicological and pharmacological tests and clinical trials, if:. The data exclusivity period lasts six years from the first registration date in the Customs Union Area. Data exclusivity period for products which benefit from patent protection in Turkey is limited to this patent period. Parallel import of drugs is strictly forbidden under Turkish law. Drugs for human use cannot be marketed unless they are Article 5, Licensing Regulation :. The drugs can only be cleared from the Turkish customs by the marketing authorisation holder. In a Circular No. This situation is not regulated under Turkish law and the licence given by the Ministry of Health is only effective on the Turkish territory, therefore it seems that virtual distribution is not possible. The licensing decisions are considered as administrative decisions in nature. The Administrative Procedure Code regulates the application for cancellation of administrative decisions or application for indemnity. Under the Code, the licensing decision can be challenged within 60 days after its notification before administrative courts or it is possible to request corrective actions from the authority as well as through an application made. Article 11,Administrative Procedure Code. The corrective action ceases the day period for filing an action and the period starts to recount after the response of the related authority or the lapse of a day period in case the authority does not give any response. The fee tariff is announced on the website of the Medicines and Medical Devices Agency every year. There are a number of different fees to be paid depending on the nature of the application. According to the fee tariff, the fee for an application to obtain a drug licence for drugs manufactured abroad is TRL45, Article 57 of the Decree Law No. There is no categorisation of drugs based on distribution criteria. Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers? Only pharmacies can sell prescription drugs to consumers. There are eligibility conditions to obtain an authorisation to sell prescription drugs Article 3 of the Law on Pharmacies and Pharmacists No. For example, to establish a pharmacy, the applicant must have Turkish citizenship and a pharmacy or medicine degree which is authorised by the Medicines and Medical Devices Agency. The Regulation on the Classification of Medical Products for Human Use defines in detail what a prescription drug is, but only defines non-prescription drugs as everything else. Due to the lack of a regulation of the over-the-counter drugs, the number of non-prescription drugs in Turkey is considerably limited and therefore all kinds of drugs must be sold in pharmacies. What drugs can an attending physician distribute and under what circumstances? Only pharmacists can distribute drugs to patients, attending physicians are not allowed to do so see h. However, physicians can give free samples to their patients. Only physicians or dentists can prescribe drugs Article 13, Law No. The Regulation on Pharmacists and Pharmacies prohibits the sale of drugs via online websites or in any other electronic platform. The Regulation on Pharmacists and Pharmacies also prohibits pharmacies from accepting the supply of drugs whose the prescription is sent via internet, fax, telephone, courier and agent or by similar means. What regulatory authority is responsible for supervising distribution activities? Drug distribution activities are supervised by the Medicines and Medical Devices Agency. The aim of the Regulation is to set out the rules, authorisation, responsibilities and the control guidelines regarding the inspection of the products which are or are suspected to be defective, or if their usage is considered risky. This surveillance activity encompasses drug factories, laboratories, trading houses, warehouses and pharmacies. The marketing authorisation grants its holder the right to distribute the relevant drug. Therefore, there is no need to have any other administrative decision to distribute drugs or to work with any distribution channels. However, all distribution activities are subject to the control of the Medicines and Medical Devices Agency Agency , which can impose sanctions. What are the legal consequences of non-compliance with consumer distribution laws? Under the Law No. Other acts violating the Regulation can be sanctioned with an administrative monetary fine as well Article 20, Law No. The withdrawal, collection and destruction decisions are implemented in line with the principles set out in the Regulation on Withdrawal. In case the withdrawn or collected defective products are damaging to health, the provisions of the Penal Code Official Gazette No. These fines are foreseen in case of a violation of this law which sets out the obligations of the producers and distributors of any product including drugs. Under the Penal Code, the sale of decayed or otherwise damaged food or drugs and the production or selling of drugs that risk the life and health of others is a crime. Such a crime is punishable with imprisonment from one year to five years, as well as a punitive fine of up to 1, daily units, which amounts to approximately up to TRL ,, paid to the state Articles and , Penal Code. Drugs cannot be sold directly from the pharmaceutical company to the consumers patients. In the Turkish pharmaceutical sector there are three major types of organisations in the distribution chain:. There is no specific rule requiring the manufacturers or importers to sell drugs through wholesale. The pharmacy trading houses can carry out wholesale or retail sales only to the pharmacies Article 11, Law No. To manage a warehouse, a licence from the Pharmacy and Pharmaceutical Warehouse Authorisation Office must be obtained. An agent pharmaceutical warehouse must comply with:. What regulatory authority is responsible for supervising wholesale distribution activities? The Medicines and Medical Devices Agency is responsible for supervising wholesale distribution activities. Its decisions are considered to be administrative decisions and can be challenged see Question 6. What are the legal consequences of non-compliance with wholesale distribution laws? In case of a violation of the provisions set out by the Regulation on Pharmaceutical Warehouses and Products Stored in Pharmaceutical the provisions regulated under the Law No. The Law on Protection of Consumers aims to protect the health, safety and economic interests of consumers. In case of a violation of this obligation, an administrative monetary fine of TRL per unit of product will apply to the producers, importers and sellers. Under the Regulation, as a general rule no promotion activities are permitted for drugs which are not licensed in Turkey. It is strictly prohibited to address general public in promotional activities. The marketing authorisation or licence holder company must not encourage the prescription of its products by offering any kind of benefit to a healthcare professional. Are there other codes of conduct for the marketing of drugs for example, by professional or industrial organisations? There are codes of conduct for professionals prepared by industry organisations which are applied together with the legal regime, for example:. In addition, there are three pharmaceutical associations in Turkey which have their own codes of practice:. It is forbidden to promote drugs to the general public in Turkey Article 13, Law No. No drugs can be advertised to consumers. However, information can be provided to the general public on products that will be used in vaccination campaigns, organised actions to combat epidemics or other campaigns run by the Ministry of Health MoH to promote health as they are important in safeguarding public health upon permission of the MoH and within the scope of principles and procedures set by the MoH for such products. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them? It is forbidden to advertise any kind of drugs to the general public see Question Promotional activities can only be directed at healthcare professionals. Is it permitted to provide consumers with free samples? Under the Regulation on Promotional Activities of Human Medicinal Products, pharmaceutical companies cannot provide free samples to patients. However, physicians can provide free samples to their patients. The Ministry of Health does not regulate these kinds of commercial arrangements and currently there are no sanctions in place against such practices. Promotional activities cannot be directed at the general public Article 13, Law No. Some regulations repeat this prohibition in order to emphasise its importance. However, promotion of licensed drugs is allowed if it is aimed at healthcare professionals and includes objective, informative and factual medical data in a way that enables the healthcare professionals to form their own opinion about the product. The general rules on promotion activities apply in this area. The promotional content should therefore not be directly available to the general public and there must be precautions in place. What regulatory authority is responsible for supervising marketing activities to consumers? The Medicines and Medical Devices Agency is entitled to inspect, ex officio or upon receipt of a complaint, promotional activities and any materials and methods employed in the context of such activities. The Ministry of Health MoH can require the marketing authorisation or the licence holder to cease, terminate or correct the information provided during any promotional activity which is found to be non-compliant with the Regulation on Promotional Activities of Human Medicinal Products or deemed inappropriate for public health. Any request by the MoH must be complied with without delay. The Advertisement Board, established within the Ministry of Customs and Trade, is the sole administrative authority controlling advertisements in Turkey. The Advertisement Board is entitled to conduct an investigation ex officio or upon an individual complaint and to impose administrative monetary fines. The Council can warn, impose administrative monetary fines and may cease the broadcast of programmes that violate the prohibition. What are the legal consequences of non-compliance with consumer marketing laws? Other than the consequences mentioned under Question 25, under Article 13 of the Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation anyone who acts or operates in violation of the provisions in the Regulation will be subjected to, depending on the nature of the violation, the applicable provisions of:. Such non-compliance can also be considered as leading to an unfair competition. In this case, the general rules of the Commercial Code apply and an indemnity depending on the damage may be claimed by the injured party. Moreover, under Article 18 of the Law No. If promotion and sales are performed via the Internet, the MoH will decide whether to block their access and such decision will be communicated to the Information Technologies and Communication Agency to enforce it. For those who promote and sell products with a health declaration without the permit of the competent authority or in violation of the permit issued will be subject to an administrative fine ranging from TRL20, to , If a violation is determined, disciplinary action will be brought against healthcare professionals by their institutions and professional organisations. In the event of recurrence, the holder will be banned from engaging in promotional activities. In case of further reoccurrence of the same breach, the marketing of the product will be suspended for three months, followed by a one-year suspension, if the breach persists. Moreover, if a product representative violates the Promotion Regulation within the validity period of his proficiency certificate, the representative will receive a warning first, in case of reoccurrence, the proficiency certificate will be suspended for three months, and for one year, if the breach persists. What kinds of marketing activities are permitted in relation to professionals? The Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation governs the relationship between the pharmaceutical companies and the healthcare professionals. The Promotion Regulation also determines an exception for the prohibition of promotion even where the product has a marketing authorisation. For the purposes of pharmacovigilance, it can provide information on drugs which have a marketing authorisation but are not available in the market only if:. There is an alternative reimbursement agreement signed with the Social Security Institution. Promotion aimed at healthcare professionals must include objective, informative and factual medical data in a way that allows healthcare professionals to form their own opinions about the product. The promotional activities cannot be used to encourage unnecessary use of a product. Healthcare professional must not act in promotional activities of such products without the permission of the Ministry of Health. Promotions cannot involve sweepstakes, lottery or similar schemes. The Promotion Regulation does not allow providing, offering or promising of any benefits, whether in cash or in kind, and the healthcare professionals must not accept or request any incentive during the course of such promotional activities. No benefit in kind or in cash can be provided, offered or promised during promotional activities to physicians, dentists or pharmacists. Greeting, farewell or celebration gifts, scholarships, travel, complimentary accommodation and gift checks received from the persons that have a business, service or benefit from the relationship with the related institution are considered to be gifts. Although these provisions are directly binding for the public officers, not for the companies, non-compliance may also have consequences for companies under anti-bribery provisions of the Penal Code as they can be used in the interpretation of constitutes bribery. The industry association, Association of Research-Based Pharmaceutical Companies AIFD , interprets the regulations more strictly and obliges its members to not provide any promotional materials such as pens, notebooks and calendars to healthcare professionals. Marketing authorisation holders cannot cover, whether directly or indirectly, transportation or accommodation expenses of participants taking part in product promotion meetings. Marketing authorisation holders can sponsor healthcare professionals for participating in scientific meetings such as congresses or symposia taking place in or outside Turkey on the following conditions:. Marketing authorisation holders must notify the Medicines and Medical Devices Agency Agency of particulars of healthcare professionals to be sponsored in accordance with the Guidelines on Scientific and Product Promotion Meetings. These conditions are not valid for scientific meetings held or sponsored by the Ministry. Non-healthcare professionals cannot be invited to the meetings, and their expenses cannot be covered. However, guests of honour are excluded from this provision. The content of presentations delivered on during such sessions must be aligned with Agency-approved educational materials and diagnostic and therapeutic guidelines, and submitted to the Agency for review, as described in the guidelines. Persons appointed by the Agency can attend these meeting for inspection purposes with or without prior notice. For such meetings, application must be submitted for permission to the relevant department of the Agency. What information is it legally required to include in advertising to professionals? The Regulation lists all the information that must appear on the products. The Association of Research-Based Pharmaceutical Companies Ethics Code specifies that the following information must also be included in the promotional materials:. These information must be placed in such a position on the promotional materials that it is easily seen by the reader. In addition, the name of the active substance of the drug must appear on the promotional materials in a legible size, immediately adjacent to the most prominent display of the commercial name. Are there rules on comparisons with other products that are particularly applicable to drugs? Even though the advertising of drugs is prohibited to the public, the general provisions on comparative advertising under the Regulation on the Commercial Advertisement and Unfair Commercial Practices apply to the promotional activities of drugs to healthcare professionals. The name of the product compared must not be mentioned. The compared products must meet the same consumer needs and address the same purpose. It must be in conformity with the fair competition principles that prohibit misleading of the consumer. Comparison can be made in a promotional material under the following conditions, without making any reference to trade marks:. What other items, funding or services are permitted to be provided to professionals? Discounts are permitted under Turkish law. However, discounts cannot be linked to any promotional activities, it can be solely a commercial activity. Discounts can be provided by pharmaceutical companies to warehouses and by warehouses to pharmacies. Pharmacies may also provide discounts to patients. Free samples can only be distributed to physicians, dentists or pharmacists provided that the following conditions are fulfilled Article 9, Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation :. Sponsorship of healthcare professionals in their participation in national or international events are also subject to strict rules see Question Under Article 6 of the Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation , no personal donations can be made directly or indirectly to healthcare professionals. There are no other incentives allowed under Turkish law except the ones mentioned above. Donations are not considered incentives and are strictly regulated under the Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation. Companies must collect documents regarding transfers that have occurred within one calendar year and file their submissions within the first six months of the next year. Although this disclosure obligation is similar to the one that company members of the European Federation of Pharmaceutical Industries and Associations EFPIA must make, disclosures under the Promotion Regulation must be made to the Agency only and public disclosure is not currently expected. What regulatory authority is responsible for supervising marketing activities regarding professionals? The Medicines and Medical Devices Agency can examine, ex officio or upon receipt of a complaint, the promotional activities and any materials and methods employed in the context of such activities see Question What are the legal consequences in case of non-compliance with professional marketing laws? What kinds of activities are permitted in relation to engagement with patient organisations? What are the restrictions that are imposed on relationship with patient organisations? Under the AIFD Ethics Code, the pharmaceutical company can provide financial support or services to a patient organisation. A written agreement must be signed between the pharmaceutical company and the patient organisation and the amount of the financial support must be clearly defined. The non-financial, direct or indirect support must also be defined in the agreement. These service agreements can only be concluded if they aim to support public health or research. Every pharmaceutical company must declare the patient organisations they are supporting. This declaration must be clear and understandable to an average reader. The logos of patient organisations can be used only on their approval. Pharmaceutical companies must not insist on being the sole supporter of a patient organisation or a big project. The Ethics Code repeats the prohibition to promote drugs to the general public through patient organisations. In case of a complaint based on a violation of these provisions, the pharmaceutical company can face sanctions depending on the gravity of the violation. The authority to examine the violation differs depending on the complainant. In the case of a repetition of the same violation, there will be a heavier sanction. Are there notable recent developments or regulatory projects in the field of distribution and marketing of drugs? The Medicines and Medical Devices Agency is currently collecting opinions and comments from industry associations regarding these regulations. I don't accept I accept. Accountability, efficiency and objectivity are our main principles. Services We are a full-service law firm leading the intellectual property field among others, providing dispute management, advisory, transactional, prosecution, investigation, and regulatory markets law services to domestic and multinational corporations. Insights We share our knowledge and expertise to update our community and clients about legal developments in Turkey. Insights Thought Leadership Monthly Newsletters. Distribution Pre-conditions for distribution 1. It determines the procedures and essential information to be given on labels and packages. The Safety Regulation lists the activities conducted for monitoring, research, recording, archiving and assessing the safety of drugs for human use which have been granted registration or permit, as well as natural or legal persons conducting such activities. Exceptions Although the regulations set out the obligation to have a licence in order to distribute drugs, there are alternative ways such as compassionate use or named patient use see Question 2. Within the scope of these systems, products can be prescribed and imported without an actual licence In addition, Turkey has a compassionate use programme established under the Guidelines on Compassionate Use Programme issued by the Agency Guidelines. Licensing 3. Regulatory authority The Medicines and Medical Devices Agency Agency is the national body responsible for licensing of drugs in Turkey. Structure The requirements set out in the Regulation on Licensing of Medicinal Products for Human Use Licensing Regulation must be met in order to be granted a licence and initiate the marketing of the drugs. The persons applying for a drug licence must meet the following conditions of eligibility: Individuals must have a university degree from in pharmacy, medicine or chemical sciences and must be qualified to practise their profession in Turkey Article 7, Licensing Regulation. There is no nationality requirement for chemists. Legal entities must employ an authorised person who meets the required conditions and experience of the product for which the application is submitted. Any constituent s of the medicinal product have a well-established medical use, determined by means of detailed scientific bibliography and with a reasonable efficiency and acceptable level of safety. The medicinal product is essentially similar to a registered medicinal product and has completed its data exclusivity period. Data exclusivity applies to the original products: For which no generic registration application was submitted in Turkey before 1 January Registered for the first time in one of the countries within the Customs union Area after 1 January Drugs for human use cannot be marketed unless they are Article 5, Licensing Regulation : Registered by the Agency under the provisions of the Licensing Regulation. Imported through the alternative ways as described above. Is virtual drug distribution possible from your jurisdiction? What is the procedure to appeal legal remedy a licensing decision? What are the costs of obtaining licensing? Distribution to consumers 8. What are the different categories of drugs for distribution? Prescription drugs Only pharmacies can sell prescription drugs to consumers. Over-the-counter drugs The Regulation on the Classification of Medical Products for Human Use defines in detail what a prescription drug is, but only defines non-prescription drugs as everything else. Who is authorised to prescribe prescription drugs to consumers? What is the procedure to appeal legal remedy a distribution decision? Withdrawal, collection and destruction of the related products. Administrative monetary fines as stipulated in Law No. The substance does not conform to the formula for which the permit is granted. Preparations are made without permission and are sold knowingly. Wholesale distribution What is the legal regime regarding wholesale distribution of drugs? In the Turkish pharmaceutical sector there are three major types of organisations in the distribution chain: Pharmaceutical companies, which sell their drugs to warehouses. All drugs must be sold to patients through pharmacies. Articles and of the Penal Code also apply see Question Marketing Promotion What is the general legal regime for the marketing of drugs? Limits to marketing activities Under the Regulation, as a general rule no promotion activities are permitted for drugs which are not licensed in Turkey. There are codes of conduct for professionals prepared by industry organisations which are applied together with the legal regime, for example: The Pharmacists Deontological Rules. Marketing to consumers What is the legal regime for marketing to consumers? Products No drugs can be advertised to consumers. Regulatory authority The Medicines and Medical Devices Agency is entitled to inspect, ex officio or upon receipt of a complaint, promotional activities and any materials and methods employed in the context of such activities. Other than the consequences mentioned under Question 25, under Article 13 of the Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation anyone who acts or operates in violation of the provisions in the Regulation will be subjected to, depending on the nature of the violation, the applicable provisions of: The Penal Code see Question 3. Law No. Law on Protection of Competition dated 12 December and No. RTUK Law. Other applicable regulatory provisions. Marketing to professionals Under the Promotion Regulation, promotion to healthcare professionals occurs through: Distributing promotion materials to physicians, dentists and pharmacists, Sponsoring or holding scientific meetings and product promotion meetings with healthcare professionals that is, meetings between product representatives and physicians, dentists and pharmacists. Are there any restrictions on marketing to professionals? For the purposes of pharmacovigilance, it can provide information on drugs which have a marketing authorisation but are not available in the market only if: There is an alternative reimbursement agreement signed with the Social Security Institution. The product is imported on a name based. Frequency Product promotion representatives PPRs can promote human medicinal products at public health institutions during working hours subject to the following rules Article 10, Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation : Relevant administrative supervisors at every public health institution will designate the most suitable time period to enable meetings between PPRs and healthcare professionals for product promotion, taking account of the work schedules. Such designation cannot disrupt educational functions or provision of healthcare services to patients. Product promotion representatives calling on healthcare institutions to perform their promotional functions cannot be charged any fee, pecuniary or otherwise for example, donations or others for gaining access to the public health institution. A healthcare professional can benefit from such sponsorships four times within the same calendar year. Sponsorship is provided to the organisation holding the meeting, and not directly to an individual. For such meetings, application must be submitted for permission to the relevant department of the Agency The Association of Research-Based Pharmaceutical Companies Ethics Code specifies that the following information must also be included in the promotional materials: The dosage. Mode of administration. Side effects. In audio-visual materials such as films, video recordings and information in interactive data systems, abbreviated SmPCs must be provided in a document which is made available to all persons to whom the material is shown or sent. The audio-visual recording or interactive data system itself. Comparison can be made in a promotional material under the following conditions, without making any reference to trade marks: It is not misleading. Drugs or services for the same needs and purposes are compared. Relevant, proven and significant features are compared. Comparisons are not used to create confusion on purpose. Pejorative or derogatory statements are not included regarding the competing product or brand. Unfair advantage of the reputation of a competitor is not taken. Discounts Discounts are permitted under Turkish law. Free samples Free samples can only be distributed to physicians, dentists or pharmacists provided that the following conditions are fulfilled Article 9, Regulation on Promotional Activities of Human Medicinal Products Promotion Regulation : Marketing authorisation holders must set up and appoint qualified persons for an adequate system of records and control, for the production, importation and distribution of free promotional samples, to safely withdraw them where necessary. Upon demand, these records must be submitted to Medicines and Medical Devices Agency Agency officials electronically or in hardcopy in the format designated by the Agency. Free samples contain a quantity reduced in size. However, this requirement does not apply to enteral nutritional products and promotional samples of products which, for technical reasons, cannot be reduced. The same statement must be printed also on the inner package, where this is possible. A copy of the summaries of product characteristics SmPCs and the PIL, where available, must be provided with the promotional sample. Samples must not be provided or distributed of products containing psychotropic or narcotic substances, covered under international agreements and of products subject to national control. Enteral nutritional products with prioritised oral use, designated as taste samples are exempt from the decremental restriction of amount by years. Promotional samples may not be used as an investigational product during a clinical trial. Sponsorship of professionals Sponsorship of healthcare professionals in their participation in national or international events are also subject to strict rules see Question The donation must not lead to any unethical transaction which may be associated with any purchase of products. The donation must not encourage prescribing a specific product. The intention must always be research, education, health or improvement of care given to patients. The donation will be utilised by the entire organisation or institution, not by any individual person. Any donation of medicinal products, laboratory kits or similar items for use in clinical research must be made directly to the principal investigator. Healthcare institutions and organizations may only accept donations by receiving permission from their headquarters, or in line with the relevant guidelines issued by their headquarters. Other items, funding or services There are no other incentives allowed under Turkish law except the ones mentioned above. Healthcare institutions and organisations. Universities, unions, associations and foundations active in the field of healthcare. NGOs established for the purpose of the protection and the advancement of health. Regulatory authority The Medicines and Medical Devices Agency can examine, ex officio or upon receipt of a complaint, the promotional activities and any materials and methods employed in the context of such activities see Question The legal consequences are the same as the ones listed in Question Engagement with patient organisations There are no regulations restricting the collaboration between the pharmaceutical industry and patient organisations. Reform Download PDF. Stay Informed Subscribe to stay up to date on the latest legal insights and events of your choice. Subscribe Now.

Buying MDMA pills Turkiye