Pharmaceuticals
- Document symbol
- G/LIC/N/3/CAF/1
- Original language
- English
- Published on
- 16/12/2010
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.
In general, the Central African Republic has abolished most of its quantitative import restrictions, except on imports of sugar, pharmaceuticals and petroleum products, which have been subject to special regulations that affect all imports of products into Central African territory since 1986.Import of pharmaceuticals into the Central African Republic is subject to registration formalities. All imports of pharmaceuticals, medical and surgical consumables and all other pharmacological items into Central African territory require prior declaration to the Directorate of Pharmaceutical Services, Laboratories and Traditional Medicine (SPLMT).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Import of medicines: a prior declaration must be made to the SPLMT Directorate. This enables the SPLMT's Director to issue a receipt for the declaration, which is attached to the customs documentation and to the commercial import declaration (DIC).
Q3. The system applies to goods originating in and coming from which countries?
These different systems apply to the products mentioned above coming from all countries without exception. The customs regime applies depending on the country in question.
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 purpose of the regulations on pharmaceuticals is to protect the population's health and also to eliminate illegal imports by unauthorized persons and/or entities which compete forcefully with the official structures in place.
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?
The following are the basic texts regulating the pharmaceuticals in the Central African Republic:
Ordinance 83.083 of 31 December 1983 regulating trading activities and the supply of services in the Central African Republic;
Decree No. 94.196 of 4 June 1994 regulating the import of pharmaceuticals into the Central African Republic;
Order No. 005 of 17 January 1995 on requirements for obtaining permits to import pharmaceuticals into the Central African Republic;
Order No. 272 of 15 October 1994 setting up a multidisciplinary technical commission for pharmaceuticals in the Central African Republic;
Interministerial Order No. 040 of 17 May 2010 on declaration of the import of pharmaceuticals, medical and surgical consumables and other items that are the monopoly of pharmacists in the Central African Republic.
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?
For other products, there are no quantitative restrictions and enterprises request the volume to be imported according to supply and demand, while complying with the buffer stock margin.
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?
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.)
With the exception of sugar, pharmaceuticals and petroleum products no other products are subject to licensing. Import licensing and other similar practices are applicable to both national and foreign importers provided that they comply with the authorities' regulations.
Decisions on imports granted to importers by the competent authorities take effect as of the date of their signature and are registered and transmitted as necessary.
After receiving the decision, an importer has to complete a DIC and obtain an inspection certificate from the Veritas Bureau (BIVAC) to enable the authorities to verify whether the goods have actually been imported. Each week, the ORSM, together with the services in the Ministries responsible for trade (Competition Directorate) and for finance (Customs Directorate), monitors the actual import of the volumes authorized. If an importer is unable to import the goods within the time limit, he will not be given any import quota, even if he applies for one. The decision is ad personam and non transferable and it lapses automatically four months after having been signed.
An import decision may also be extended if the importer can prove a case of force majeure within a reasonable period before expiry of the decision's validity.
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?
Licence applications are submitted quarterly to the ORMS, which receives the import applications sent to the Minister responsible for trade, duly annotated.
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
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?
A multidisciplinary technical commission for pharmaceuticals (CTPPP) has been set up with responsibility for considering applications for permits to import pharmaceuticals into the Central African Republic. Its chair may give the Minister of Health and Population a substantiated opinion for or against the application. The commission is composed of representatives of pharmaceutical and medicines services, health and environmental services, hospitals, medicines policies and regulations bodies, surgical, gastroenterological, paediatrics, opthamological, gynaecological and obstetrical, and internal medicine services, private pharmacists, private veterinarians and a toxicologist from the Science and Health Faculty.
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?
Importers in general (new or existing) are aware that they have to file their next application at the end of the quarter. The ORSM does not make any distinction between new and existing importers. If they all meet the requirements, the ORSM gives them all an authorization in light of the remaining volume and according to needs. The same applies to other products.
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?
All traders, without exception, must complete a DIC for all import/export transactions in the Central African Republic. This is the method used by the Government to securitize customs revenue, on the one hand, and to keep trade statistics, on the other.
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 export licensing regime was abolished in the Central African Republic in 1986. Exporters therefore only have to submit a DIC before exporting their goods. The importing country must verify the export permit from the BIVAC, authorized for this purpose. The BIVAC then issues the DIC, which is countersigned by the Ministry responsible for trade in order to allow the importer to import the goods.
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Such a provision does not yet exist in the Central African Republic.
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)?
According to the texts in effect, counterfeit goods and the means used to import them into the Central African Republic are automatically seized.
Q7.b. Can a licence be granted immediately on request?
See the replies to section IX.
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.
The replies to all these questions can be found in section VII
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?
The replies to all these questions can be found in section VII
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?
Any laboratory whose application for an import permit has been rejected may file a new application after a period of two (2) years.
An import permit may be renewed every five (5) years. The application for renewal is sent to the Minister of Public Health and Population in two (2) copies comprising:
A letter applying for renewal addressed to the Minister of Health;
a marketing authorization (AMN) from the country of origin;
a retail sale certificate (AVC) for the country of origin for imported goods;
the price and cost of daily treatment.
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?
There is no registration system. All import transactions for such products require submission of the decisions allowing the operators to engage in such transactions. The list of those authorized is automatically published, thereby informing other economic operators.
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?
In the case of pharmaceuticals, applications for registration must be accompanied by an authentic copy of the AMN of the exporting country and the receipt for the cost of registration formalities issued by the Directorate of Pharmacies and Medicines.
Q11. What documents are required upon actual importation?
The DIC; the pro forma invoice of the supplier and the administrative fees payable to the Veritas Bureau (BIVAC), given responsibility for this purpose by the State, together with a copy of the decision authorizing the importer to import the goods in question.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
No reply has been given.
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 reply has been given.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
No reply has been given.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No reply has been given.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
No reply has been given.
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 reply has been given.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
No reply has been given.
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 reply has been given.