Narcotic/psychotropic substances
- Document symbol
- G/LIC/N/3/ALB/13
- Original language
- English
- Published on
- 22/02/2024
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
The Ministry of Health and Social Protection grants licenses for subjects in order to import/export/trade narcotic/psychotropic substances and precursors in accordance with Law No. 7975, dated 26 July 1995 "On Narcotics and Psychotropic Substances" as amended and No. 8874, dated 29 March 2002 "On the control of substances used in the illicit manufacture of narcotic and psychotropic substances".
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
The license is given only to the subjects that fulfil the documentation according to the abovementioned laws and only these companies are allowed to import/export/trade the substances that are included in the laws (that are in conformity with the lists published by the International Narcotics Control Board (INCB) in Vienna.
Q3. The system applies to goods originating in and coming from which countries?
Drugs that are imported in the Republic of Albania are registered (have market authorization) and according to the Law No. 105/2014 "On drugs and pharmaceutical system" as amended the minister responsible for health grants marketing authorization for:
(a) drugs manufactured in our country;
(b) drugs that have received marketing authorization and are circulating in one of the countries of the European Union, the United States of America, Canada, Turkey, Switzerland, Israel, Japan, Australia;
(c) drugs manufactured in the Balkan countries, only when they have received marketing authorization and circulate in their country;
(d) drugs equipped with marketing authorization from the European Medicines Evaluation Agency (EMA) or the Food and Drug Administration (FDA) of the United States of America.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The licensed companies authorized to import these drugs/substances are allowed to import restricted quantities according to the quantities allowed to the Republic of Albania by the INCB.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
Law No.7975, dated 26 July 1995 "On narcotics and psychotropic substances" amended Law No. 8874, dated 29 March 2002 "On the control of substances used in the illicit manufacture of narcotic and psychotropic substances" amended Law No. 105/2014 "On drugs and pharmaceutical system" amended.
The licenses and authorizations for import/export are given only according to the abovementioned laws.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
The quantities of these substances that are allowed to be imported in the Republic of Albania are determined for every calendar year. The proposal of the quantity is made by the Ministry of Health based on the requests of the authorized companies for each year also on the needs of the local hospitals needs. These requests are given to the INCB which is the entity that grants and approves the quantities allowed to be imported. In the cases of the need to increase the quantities for the calendar year another request can be made to the INCB, request that has to be approved.
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Every three months the Ministry of Health and Social Protection of Albania reports to the INCB the quantities imported/exported for narcotics and psychotropic substances and every year reports the quantities imported/exported for narcotics/psychotropics/precursors in the previous year and furnishes the quantities needed for the next year, quantities that must be approved by the Board.
The licenses are given to subjects that fulfil the proper documentation according to the abovementioned laws and are valid as long as the subjects does not make any changes to the structure of the company (the location, the technical director etc.)
The import/export authorization is given with a special permit (import/export authorization) by the Minister of Health and Social Protection for each import/export (for every specific amount with an expiry date and batch number) for every drug that goes through the customs.
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
For every narcotic/psychotropic/precursor that goes through the customs an import/export authorization is given with a special permit by the Minister of Health and Social Protection. These authorizations are given only to authorized licensed companies for registered drugs or drugs that are needed for hospital/ambulatory use ore samples needed by the National Agency for Drugs and Medical Devices for registration purposes.
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
The companies can apply for licences and authorizations at any time.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
The Ministry grants the import/export authorization no longer than 28 days after the application has been made and grants or refuses the licence five months after the request.
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
They are not related as mentioned above.
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
For narcotic/psychotropic/precursors the companies must get an import/export authorization from the Ministry of Health and Social Protection and then another permit issued by the National Agency for Drugs and Medical Devices.
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
The quantities requested by the Ministry to the INCB are based on the quantities requested by the companies, so each company can import the requested amount if is approved by the Board (INCB).
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
In cases of exports, the import permit from the exporting country is needed in order to issue the export authorization.
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
The documents issued by the other country are furnished by the company that applies for the import/export authorization.
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
The export authorization can be granted for drugs that are not registered (don't have market authorization) in the Republic of Albania.
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
Q7.b. Can a licence be granted immediately on request?
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
The licence can be refused if not according to the proper criteria. After the licence is issued, it can be revoked if there is any sign that the company is not acting in compliance with the law.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All subjects that apply for licence are issued with license (if they meet the proper criteria) by the Commission of Licencing for Narcotics and Precursors with no fee. After getting the License by the Commission the companies can get authorizations for import/export by the Ministry and National Agency with no fee for registered drugs and samples and there is a fee of 5,000 Albanian LEK for each dose for unregistered drugs.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
For the application is needed a letter of request with the proper information (trade name, active ingredients, pharmaceutical form, dose, batch number, expiry date, name of exporter and manufacturer), a proforma invoice, certificate of analyse/origin and packing list.
Q11. What documents are required upon actual importation?
For the application is needed a letter of request with the proper information (trade name, active ingredients, pharmaceutical form, dose, batch number, expiry date, name of exporter and manufacturer), a proforma invoice, certificate of analyse/origin and packing list.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No, there is no fee for licence issuing.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No, there is no fee for any deposit or advance payment requirement associated with the issue of licences.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The licenses issued by the Commission of Licencing for Narcotics and Precursors are valid as long as the company does not make any change according to the data of the Licence issued by the National Center of Business Licencing.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No, there is no penalty for the non-utilization of a licence or a portion of a licence.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No, licences are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
No, there are no other conditions attached to the issue of a licence.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No, there are no other administrative procedures.
Q19. Is foreign exchange automatically provided by the banking authorities for goods to be imported? Is a licence required as a condition to obtaining foreign exchange? Is foreign exchange always available to cover licences issued? What formalities must be fulfilled for obtaining the foreign exchange?
No, foreign exchange is not automatically provided by the banking authorities for goods to be imported. Yes, a licence required as a condition to obtaining foreign exchange. No, foreign exchange is not always available to cover licences issued.