Outline of the system
All medicines and pharmaceutical products must be registered with the Pharmacy Board prior to import and marketing in the country.
In addition, certain specific category of medicines and pharmaceutical products as well as chemicals require a licence for their import. These include:
• Antibiotics, vaccines and any therapeutic substance
• Schedule I, dangerous drugs
The substances listed in Schedule I of the Dangerous Drugs Act are only meant for the use of Forensic Science Services in quantities not exceeding those strictly requested for the purpose in question. They are not subject to any quota.
For each consignment of antibiotics, vaccines and therapeutic substances imported, the importer (Pharmaceutical Wholesaler) is required to submit an application for a permit as specified under Section 25 of the Pharmacy Act indicating the name of the product(s) and quantity in respect of each product being imported. An import permit is then delivered to the importer accordingly.
As regards to dangerous drugs, it is mandatory under the International Conventions that a permit be issued by the regulatory authority for the import of substances listed in Schedule I of the Dangerous Drugs Act 2000.
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 (medicinal, scientific, and educational). 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.
Questions for products under restriction as to the quantity or value of imports
The system applies to products originating from which country?
The licensing system applies to goods coming from any country.
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?
What persons or firms are eligible to apply for a licence?
Any person, firm or institution is eligible to apply for licences. Issue of licence is applicable to both importers and producers of goods. Pharmaceutical wholesalers are registered entities with the Pharmacy Board. They also hold a trading licence from the local authorities.
Is there a registration fee?
Is there a published list of authorized importers?
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?
It is advisable to apply for the permit/licence prior to import.
Are there any limitations as to the period of the year during which application for licence can be made? If so, explain
There is no time limit for submitting an application for permit /licence in the case of therapeutic substances including antibiotics and vaccines, as well as for chemicals and substances listed in Schedule I of the Dangerous Drugs Act. An application can be submitted any time an import is to be effected during the year.
Issuing the license
Can a licence be granted immediately on request?
Licence/permit may be issued immediately upon request and at time when goods have arrived at the port only in the case of therapeutic substances including antibiotics and vaccines, on a consignment basis.
For Schedule I dangerous drugs, an import licence/permit is issued within a couple of days of submission of request.
Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence
Licence/permit may be issued immediately upon request and at time when goods have arrived at the port only in the case of therapeutic substances including antibiotics and vaccines. However, it is advisable to apply for the permit/licence/certificate prior to import.
Which administrative body is responsible for approving application of licences?
The import permit is issued by the Pharmacy Board of the Ministry of Health and Wellness.
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?
The issue of a licence is subject to any additional information or clarification that maybe required in respect of same.
For Schedule I, dangerous drugs, 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.
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.
What is the amount of the fee or charge?
Wholesale Pharmacies pay a registration fee for a licence to operate and an annual licence renewal fee.
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 is 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?
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 licence/permit may be refused in the case of importation of pharmaceutical products including Schedule I, dangerous drugs if the applicant is not a registered pharmaceutical wholesaler, laboratory or an educational institution.
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. Release of any consignment is carried out under the supervision of a government pharmacist.
Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
All pharmaceutical products are required to be registered by the Pharmacy Board prior to import and marketing in Mauritius.
Conditions of licensing
What is the period of validity of a licence? Can the validity be extended? How?
The validity of the licence for import of schedule I, dangerous drugs and chemicals is till 31 December. It may be extended upon request if there is a delay in supply. As regards import permit for vaccines, antibiotics, etc. the permit is issued on consignment basis at time of arrival of the goods.
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?