No. : 665/6927 Date : April 16, 2016 To : All pharmaceutical companies

Transcription

1 No. : 665/6927 Date : April 16, 2016 To : All pharmaceutical companies Respectfully; In the name of God Islamic Rep. of Iran Food & Drug Administration Gen. Dept. of Supervision & Evaluation of Drug & Narcotics In direction of the obligations of the Organization to clarify and stabilize pharmaceutical concepts and process of the country, meantime attaching Instruction of the clarification of definitions, programs and policies of the President of the Food & Drug Administration for the year 2016 (the Letter no.5284 dated April 11, 2016), the following cases are informed: 1. This Gen. Department is obliged and must announce list of all locally manufactured and imported pharmaceutical products (drugs) and starting materials, subject to the Custom tariff, prohibited importation and approved prices until May 04, The announced definitions and programs will be executable from the said date; therefore, it would be appreciated to pay attention to these cases in your future planning. 2. Regarding locally manufactured drugs that often incur loss, the price will be corrected to some extent and for the remaining drugs or new products, under license and generic brand, the new rules of pricing that will be announced till May 05, 2016, is applicable. The policy of free pricing is still applied to OTC drugs on the condition of exact adherence to the approval of the Commission guidelines (necessary and important points in this regard is following coding, correct and approved packaging and non-applying new price to the available stock in the market) 3. Regarding imported drugs that do not have local manufacturers, general policy is to have no quota, decreasing prices and decreasing currency allocation, therefore, the basis of pricing on such drugs will be the least reasonable price offered by the Emergency Pharmaceutical Centers (EPC) with the priority of importation being with is the official representatives of MAHs. Moreover, the price of the imported drugs will be fixed in Rial currency for the year (1395). 4. Regarding the imported drugs that have local manufacturing, for which the attached guideline does not apply, the policy is absolute ban of importation and under particular conditions and in case the local manufacturer is not able to support the demand, importation is allowed based on applying customs tariff and reducing margins. The regulations will be more rigid for single prescription drugs out of the Iran Drug List (IDL). 5. At present, due to the macro policies of the country in this relation, Legal Commission will not approve registration and importation (also renewal of registration) of drugs that have similar local production. 6. Making use of information and electronic communication systems is a priority and requirement of this Organization and it is not dispensable. At the end, we appreciate patience of the companies for some of the delays and recent disorders that have been occurred because of the speedy change of the existing processes in order to adapt with the said policies. Dr. Akbar Abdollahi Asl: Gen. Director of Supervision & Evaluation of Drug & Narcotics Translation is accurate Translator is competent to translate Tehran, April 19, 2016 Laus Deo

2 In the name of God Islamic Rep. of Iran Food & Drug Administration Gen. Dept. of Supervision & Evaluation of Drug & Narcotics No. : 665/5284 Date : April 11, 2016 To : Gen. Director of Supervision on Drug & Narcotics Subject: Definitions, goals and plans of the drug for the year 2016 Due to the approvals of the Council of Pharmaceutical Policy making, Council of Health Technology and Legal Commissions of the Article 20 and necessity of the clarification of concepts and process in the scope of registration and supervision on procurement, manufacturing and importing drug, hereby, the following cases are informed for the purpose of information of the beneficiaries: Article 1: Definitions Pharmaceutical company: Every company that is active in the field of manufacturing, contract manufacturing, official imports, emergency and single prescription, sales and marketing of any type of pharmaceutical products based on its statute and authorizations obtained from this administration. Drug registration: A process in which a pharmaceutical company submits required documents in regards with qualitative and quantitative supply of a product based on the technical regulations to the Pharmaceuticals and Narcotics Bureau and has them approved by the Legal Commission for Manufacturing & Importing pharmaceuticals and accepts all consequent responsibilities of the product. Registration certificate is a legal document that is awarded to the license holder after completion of this process in order to attain the responsibility of the product. No pharmaceutical product may enter the supply chain unless registered except in emergency situations. Locally manufactured products (non-biologic): Any registered non-biologic product that is manufactured from at least one step before secondary packaging. In case the primary packaging is done locally, it should generate an added value of at least half of the necessary approved customs tariff. Locally manufactured API and excipients: a registered drug API or excipient which passes through at least one chemical step in Iran, in a way that the CAS number of the ingoing and out coming material is different and generates at least a value of half customs tariff for the country. Locally manufactured Packaging material: Registered packaging material that generates an added value of at least half of the approved customs tariff for the country. Locally manufactured biologic drugs: A registered product for which the manufacturing site of the API from the cell culture, formulation and packaging is located in Iran. Emergency product: A drug which exists in the Iran Drug List (IDL) and for any reason its official supply (manufacturing & importation) is not sufficient to meet market demand and does not have any substitute according to the approval of the Scientific Organization or Associations. Single prescription drug: A drug not on Iran Drug List (IDL) that is imported because of the need of a number of individuals (under 100 persons) per year based on current related regulations. In cases that the quantity of the product is for more than 100 persons' need, the Iran drug review and compilation council will be notified.

3 Over the counter products: A drug which exists in Iran Drug List (IDL) and its supply in pharmacy does not need physician's prescription. In order to register these products for the purpose of local manufacturing, availability of a main brand as OTC issued by an international regulatory body which is approved by the legal commission suffices. Under license Product: Registered locally manufactured products that are manufactured in the country under the license of a foreign pharmaceutical company. Article 2: Practical actions and plans to empower local pharmaceutical companies Elimination of IDL application for one product against every five million dollars export of that drug per year by the license holder. This amount will be one million dollar for companies that are considered as scientific based. Elimination of registration tracking for one product against every five million dollars export of that drug per year by the license holder. This amount will be one million dollar for companies that are considered as scientific based. Elimination of registration tracking for one product against manufacturing of each main brand as under license Elimination of registration tracking of two products against performing one clinical trial based on GCP To apply customs tariff and minimum pricing margins for products whose locally manufactured counterparts alleviate the patients demand. Acceleration and facilitating the pricing procedure for drugs manufactured in GMP certified production lines. One year delay in registration for two products against lack of manufacturing of each obtained license by creating shortage in the country for at least two weeks. Article 3: Expansion of investment of well-known pharmaceutical companies in the country Acceleration of the process of registration (Fast track) in case the registration applicant is the main international company LH/MAH Facilitation and acceleration of entering the drug to the Iran Drug List (IDL) in the case of registration with the purpose of coverage of a larger territory other than Iran aiming to export Obligation to register drugs of new companies by LH/MAH only Mandatory registration of new imported drugs and renewal of the registration of current drugs of available companies with a sales record of more than five million dollars per year by LH/MAH only Exemption from tariff payment of under license manufacturing of the generic drug for six months and for under license manufacturing of main brand, for one year and in cases that the foreign company intends to invest directly and establish a factory in Iran, this duration will be at most three years (on the condition of progress of the project) Stability and uniformity of the concepts and processes and regulations for registration, pricing and tariffs and currency allocation till the end of the year.

4 Article 4: Upgrading quality level of the locally manufactured drugs Elimination of Iran Drug List (IDL) application for two products for local manufacturing companies holding at least one international GMP approval Deletion of registration tracking for ten products for local manufacturing companies for each international GMP approval and for four products for each Iran FDA GMP approval Deletion of registration tracking for one product of the local manufacturing companies against financing at least twenty PMS studies. Non renewal of the licenses for medicinal packaging which may be opened in the pharmacy except for hospital drugs Stopping production lines with critical GMP observations New license will not be issued for manufacturing lines without GMP approval Article 5: Upgrading quality level of the OTC drugs Registration of OTC drugs with new packs or under license as fast track Acceleration and facilitation of OTC Iran Drug List (IDL) inclusion by Iran drug review and compilation council Elimination of Iran Drug List (IDL) application process for an OTC drug for each five million dollar export per year by LH company Elimination of Iran Drug List (IDL) application process for a main brand OTC drug in the case of local under license manufacturing Article 6: Upgrading qualitative & quantitative level of starting materials in the country Issuing registration license for starting materials in case of following all related quality principles and support in terms of tariff Elimination of registration tracking for products manufactured from starting materials which are manufactured in Iran for the first time (obligation of consumption for three years) To create exclusivity at most for two years from the date of registration for a new product which is manufactured for the first time from starting materials locally manufactured in Iran. Deletion of customs tariff for a main brand for each under license manufactured main brand that uses locally manufactured starting materials. Article 7: Clarification in the procedures, regulations and information To prepare and announce guidelines and regulations based on i this Instruction at most till 4 th of May To prepare and declare new rules of price and tariff of drugs at most until 4 th of May To prepare and declare list of all starting materials subject to the tariff in the year 2016 based on the above mentioned regulations at most until 4 th of May To prepare and declare list of all prohibited starting materials in the year 2016 because of supporting local manufacturing at most until 4 th of May

5 Note To provide and announce the list of all drugs subject to the tariff of the year 2016 based on the above-mentioned regulations at most until 4 th of May To prepare and declare all prohibited drugs because of existence of similar local manufacturing in the year 2016 at most until the 4 th of May To provide and declare the list of approved prices for all importing drugs for the year 2016 based on the above-mentioned regulations at most until 4 th of May Issuance of import and clearance licenses for medicines and starting materials through centralized system Issuance of medicines and starting materials license through centralized system Registration license will not be issued for companies that have not applied for the coding and track ad trace system yet. Issuance of release permit only for products having track and trace code All above mentioned regulations for registration of pharmaceutical products without completion of Iran Drug List (IDL) formalities is subject and due to having approval from one of the valid regulatory bodies. Signed by Dr. Rasoul Dinarvand Deputy of the Minister & President of IFDA Translation is accurate Translator is competent to translate Tehran, April 19, 2016 Laus Deo