Outline of the system
The Pharmacy Board is the regulatory body under the Pharmacy Act solely responsible for the issue of a licence/permit.
All medicines and pharmaceutical products must be registered with the Pharmacy Board prior to import and marketing in the country.
In addition, a certain specific category of medicines and pharmaceutical products as well as chemicals require a licence for their import. These include dangerous drugs as defined under Section 3 of the Dangerous Drugs Act 2000.
As regards to dangerous drugs, it is mandatory under the International Conventions that a permit be issued by the regulatory authority for the import/export of substances listed in Schedules II and III of the Dangerous Drugs Act 2000.
The substances listed in Schedule IV of the Dangerous Drugs Act 2000 are used in the manufacture of narcotic drugs and psychotropic substances as classified by the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, or otherwise, are included as precursors in Schedule IV.
They are also subject to regulatory control under the International Convention to Prevent Illicit Trafficking and Diversion to ensure that importation is for bona fide purposes.
Nature of licensing
If Automatic, administrative purpose
If Non-Automatic, description of the notified Non-Automatic Licensing regime
Products under restriction as to the quantity or value of imports
The licensing process is intended to exercise control over import as per international requirements to ensure that the goods are destined for legitimate use.
Questions for products under restriction as to the quantity or value of imports
Import of Schedules II, III and IV dangerous drugs are, subject to a yearly quota which is established as follows: Please see Answers 6.1-6.11.
The system applies to products originating from which country?
The licensing system applies to goods coming from all countries
Expected duration of licensing procedure
Is the licensing statutorily required?
As mentioned above, they are governed by the provisions of the Pharmacy Act, 1983 and Dangerous Drugs Act 2000 as well as the respective regulations under the Acts.
Does the legislation leave designation of products to be subject to licensing to administrative discretion?
Being mandatory requirements, any amendments to the control measures will require amendments to the respective Acts.
Is it possible for the government to abolish the system without legislative approval?
Eligibility of applicants
Is there a system of registration of persons or firms permitted to engage in importation?
Pharmaceutical products can only be imported by wholesale pharmacies, registered by the Pharmacy Board, under the supervision of pharmacists.
What persons or firms are eligible to apply for a licence?
Pharmaceutical products can only be imported by wholesale pharmacies, registered by the Pharmacy Board, under the supervision of pharmacists. They also hold a trading licence from the local authorities. Similarly, the importers or dealers involved in the trade of chemicals (Precursors) need to be licenced by the local authorities and (Dangerous Chemicals Control Board which operates under the Ministry of Health and Wellness.
Is there a registration fee?
Is there a published list of authorized importers?
A list of registered pharmaceutical wholesalers is available at the Ministry of Health and Wellness. They also hold a trading licence from the local authorities.
Contact point for information on eligibility
Submission of an application
Administrative body(ies) for submission of an application
Pharmacy Board, Ministry of Health and Wellness
What information is required in applications?
The applicant is required to submit the required information as per international procedures as recommended by WHO
What documents is the importer required to supply with the application?
A signed application, prescribed by regulations under the Pharmacy Act, accompanied by a proforma invoice should be submitted to the Regulatory Unit for request of an import permit.
Window of submission of an application
How far in advance of importation must application for a licence be made?
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
Issuing the license
Can a licence be granted immediately on request?
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Which administrative body is responsible for approving application of licences?
Must the applications be passed on to other organs for visa, note or approval?
Are there any other conditions attached to the issue of a licence?
For Schedule IV items of the Dangerous Drugs Act (Precursor Chemicals), the procedure for the issue of permit/certificate follows the same pathway as for schedule II and III dangerous drugs except that the authority in the exporting country will issue a Pre-Export Notification (PEN) certificate requesting for confirmation from the authority of the importing country on the authenticity of the import prior to shipment. There are no such conditions that licences are issued exclusively for export only.
Fees and other administrative charges
Is there any licensing fee or administrative charge?
There is no processing fee applicable to the application for an import permit.
Wholesale pharmacies pay a registration fee for a licence to operate and an annual licence renewal fee.
What is the amount of the fee or charge?
Only pharmaceutical products registered with the Pharmacy Board are authorised to be imported and marketed in the country. A processing fee of MUR 2,500 and a registration fee of MUR 5,000 per product (non-refundable).
Fees are also applicable for extension in line and variations of imported pharmaceutical products as follows :
- Change in shelf life 2,000 MUR
- Change in manufacturing site/distribution channel 2,000 MUR
- Extension in line of product 2,000 MUR
- Change in trade name 2,000 MUR
- Change in /additional pack size 1,000 MUR
- Change in pack design (primary pack) 1,000 MUR
- Change in design (secondary pack) 1,000 MUR
- Change in packing material 1,000 MUR
- Change in label design 1,000 MUR
Is there any deposit or advance payment required associated with the issue of licences?
There is no deposit or advance payment for the issue of licences.
Amount or rate?
Is it refundable?
What is the period of retention?
What is the purpose of this requirement?
Refusal of an application
Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria?
An application for clearance may be refused in the case of importation of pharmaceutical products including dangerous drugs (Schedules II, III and IV), if the applicant is not a registered importer with the Pharmacy Board.
Are the reasons for any refusal given to applicants?
Have applicants a right of appeal in the event of refusal to issue a licence?
If so, to what bodies and under what procedures?
Are there any limitations as to the period of year during which importation may be made?
What documents are required upon actual importation?
A copy of the import licence must be submitted along with the invoice for release authorisation by the Regulatory Unit.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The validity of a licence for pharmaceutical products is subject to renewable every year, upon payment of MUR 2,000.
Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for the non-utilisation of licence.
Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licence is not transferable between importers.
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?
The following questions are only 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)
Where is information on allocation and formalities for licences published? 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?
At the end of every year, pharmaceutical wholesalers and companies dealing in precursors are required to submit a return of their transactions indicating opening stock, quantity purchased or imported, sold or utilised during the current year and balance in hand.
They are also required to submit their request in respect of their requirements for the subsequent year. Each company receives its annual quota which is controlled by the Regulatory unit of the pharmacy department under the supervision of the directorate.
Is the size of the quota determined: on 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 a fresh licence on a six-monthly or quarterly basis?
Annual quota is worked out on the basis of the data submitted, i.e., their consumption and their forecasted projects. Adjustments (increase), if any, to the quota are effected in the course of the year, however, full justifications must be provided.
Are licences allocated 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 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)
The requirement at national level is worked out and submitted to the International Narcotics Control Board (INCB) in Vienna for the establishment of national quota especially for dangerous drugs Schedule II (narcotics) which, are recorded and published. Unused quotas cannot be carried forward for a succeeding year, i.e., the quota is valid from 1 January to 31 December.
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?
Once a quota is established, import may be effected in a staggered manner during the year.
What are the minimum and maximum lengths of time for processing applications?
The issue of the import permit/certificate is effected within a couple of days of submission of request (application).
How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
The import permit is issued by the Pharmacy Board of the Ministry of Health and Wellness.
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?
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?
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 where imports are allocated 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 importer will have to forward a copy of the import permit/certificate to the exporter who will forward a copy of same to the authority in the exporting country in view of obtaining an export licence to enable shipment of the consignment of the dangerous drugs.
Similarly, in the case of Schedule IV dangerous drugs (Precursor Chemicals), issue of a licence may be refused if it is suspected that the import of the chemicals is not for legitimate use. There is no right of appeal in the event of a refusal of a licence.
Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?