Antibiotics, vaccines and therapeutic substances and, dangerous drugs (Schedule I)
- Document symbol
- G/LIC/N/3/MUS/13
- Original language
- English
- Published on
- 15/12/2023
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.
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.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
For each consignment of an antibiotic, vaccine and a therapeutic substance, 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.
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.
Q3. The system applies to goods originating in and coming from which countries?
The licensing system applies to goods coming from all countries.
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 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).
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?
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. Being mandatory requirements, any amendments to the control measures will require amendments to the respective Acts.
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?
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.)
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?
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?
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?
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?
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?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
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)?
It is advisable to apply for the permit/licence prior to import.
Q7.b. 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.
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.
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.
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 import permit is issued by the Pharmacy Board of the Ministry of Health and Wellness.
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?
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.
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?
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.
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?
The applicant is required to submit the required information as per international procedures as recommended by WHO. 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.
Q11. 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.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
There is no processing fee applicable to the application for Import permit.
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
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 deposit.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence 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.
Q15. 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.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
The licence is 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?
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.
Other Procedural Requirements
Q18. 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.
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?
Yes