Hi mick_healy!!
All trade licences are under the regulation of the Ministry of Health
& Quality of Life.
- General guidelines -
The following import documents are required by Customs:
Invoice, showing the FOB and CIF value of goods
Packing list
Bill of lading / Airway bill
Bill of entry
Insurance certificate
Certificate of inspection
Certificate of origin
Import permits
The following certificates of origin are accepted by Customs:
EUR 1 - certificate issued under the Cotonou Convention
COMESA - certificates of origin
SADC - certificates of origin
IOC - Certificates of origin
Certificates issued by Chambers of Commerce or other approved bodies.
Importation Permits:
Pharmaceutical products necessitate an import permit. Import permits
normally require clearance from the relevant Authorities, for example
Ministry of Health for prepared foods, drugs, and chemicals with
potential adverse effects on health.
"Importation and control of drugs:
The Ministry of Health has drawn up a list of essential substances
required to meet the country's medical needs. Controlled drugs like
psychotropic drugs and narcotics, which are subject to international
control under International Conventions, are imported through an
import-export licensing system. The quantities of these drugs are
strictly controlled in order to ensure their legitimate use.
As regards the import of other drugs for use in the public sector,
they are subject to international tenders. Imported pharmaceuticals
must be registered for sale in their country of origin. Registered
wholesale pharmaceutical establishments import medicines for sale in
the private sector. They are required to be registered with the
Pharmacy Board prior to importation in accordance with the Pharmacy
Act"
From the Mauritius Chamber of Commerce and Industry:
http://www.mcci.org/IT_imports.htm
Extract from "GUIDELINES & PROCEDURES IN RELATION TO APPLICATIONS FOR
TRADE LICENCES" from Ministry of Health & Quality of Life:
" GENERAL GUIDELINES:
The application for any trade licence shall be made in writing in such
forms as may be approved by the relevant Council (in this case the
Pharmacy Board) (Sect. 104 of the Local Government Act).
Every application form for any permit or licence accompanied by the
undermentioned documents, shall be submitted to the Regional Health
Office of the Ministry of Health and Quality of Life for a health
clearance:
- a site/location plan
- a lay-out plan of the proposed premises
- a copy of the Development Permit for the trade applied for (Local Govt. Act)
- a copy of the Permit to run electric motors where applicable
(Building Act). Where a proposed trade premises does not require a
Development Permit, a written statement to that effect shall be
forwarded by the Local Authority to the Regional Health Office,
- a copy of the Preliminary Environmental Report or Environmental
Impact Assessment Licence in respect of undertakings specified under
Part A or Part B and Part C of the First Schedule, (Section 15(2)) of
the Environmental Protection Act), and
- the details such as the exact address and phone number of the applicant "
...
"GROUP XI:
CLASSIFIED TRADES
?Pharmacies (Wholesale ? Retail)
?Pharmacy (Ayurvedic)
?Seller of Ayurvedic products
GUIDELINES
1. Relevant parts of the General Guidelines shall apply.
2. No trade Licences for Pharmacies shall be issued unless they are
licenced under the Pharmacy Board of the Ministry of Health and
Quality of Life. Trades enlisted in Group XI shall comply with the
following structural hygiene provisions and conditions:-
(i) Proper store and storage facilities shall be provided for the
storage of drugs and sterile items stored and displayed for sale so as
to contain risks of cross contamination by rodents and insects. Racks
or stages leaving at least 300 mm clear space from floor shall be
provided in store to stack stock of drugs thereon.
(ii) Proper chilling and/or freezing facilities shall be provided for
storage of drugs which require chilled or freezing temperature for the
purpose.
(iii) A separate drug preparation room provided with wash basin, wash
hand basin fitted with running water supply and table topped with an
impervious, impermeable material such as ceramic tiles, unjointed
aluminium or stainless steel sheet, sterilising unit (if required) and
containers fitted with tight fitting lids shall be provided therein.
(iv) Appropriate and adequate sanitary facilities (i.e. WCs and wash
hand basins) shall be provided for employees.
(v) A messroom shall be provided for the employees
(vi) All wastewaters generated shall be disposed of in a way as
approved by the Ministry of Health & Quality of Life.
(vii) All solid wastes generated shall be properly collected and
disposed of as approved by the Ministry of Health and Quality of Life.
(viii) Continuous water supply shall be ensured on premises and
provision of fibre-glass water storage tanks of adequate size shall be
provided. "
http://ncb.intnet.mu/moh/download/tradguid.doc
According to the Pharmacy ACT, subscribed by Mauritius, permits for
importing therapeutic substances are only issued to:
Pharmacists or authorized persons (a person who proves that he
requires the therapeutic substance for purposes of scientific
education or research).
The following paragraphs was summed up from the Pharmacy Act:
- Import of drugs:
·Only a person with permit can do that, and in the act this is not
specified if he must be a pharmacist, but the therapeutic substances
rule is clear inthis point so a pharmacist in charge is needed.
·Any person who wishes to obtain a permit shall make a written
application to the Pharmacy Board. (later I will tell you about this
board).
·On receipt of such, the Board may refer the application to the Trade
and Therapeutics Committee and in the light of the recommendations of
the Committee, shall decide whether or not to approve the application.
·Where the application is approved by the Board, the Permanent
Secretary shall issue the permit on such conditions as he thinks fit.
·No pharmacist in charge of a pharmacy shall, for himself or on behalf
of another person, import any drug for sale by wholesale (this point
helps to clarify the need of a pharmacist).
- Pharmacy Board:
(1) There is established for the purposes of this Act a Pharmacy Board
which shall consist of ?
(a) the Chief Medical Officer, Chairman;
(b) the Chief Government Pharmacist;
(c) 5 pharmacists appointed by the Minister
(d) a law officer designated by the Attorney-General.
(2) A Government Pharmacist designated by the Minister shall act as
Registrar of the Board.
- Trade and Therapeutics Committee:
(1) There is established for the purposes of this Act a Trade and
Therapeutics Committee which shall advise the Board on ?
(a) any matter relating to the manufacture and importation of
pharmaceutical products;
(b) the compilation and maintenance of a National Drugs Formulary;
(c) any reported adverse effect caused by any drug and any measure
required to be taken to protect public health;
(d) any area which is in need of a pharmacy.
(e) any matter referred to it by the Board.
(2) The Committee shall consist of ?
(a) the Principal Medical Officer, Chairman;
(b) the Chief Government Pharmacist;
(c) a representative of the Ministry of Trade and Shipping;
(d) 3 medical practitioners appointed by the Minister;
(e) 2 pharmacists appointed by the Minister.
At the "Ministry of Health & Quality of Life - Senior Staff" page you
will find contact info for some of the Pharmacy Board members:
http://health.gov.mu/staff.htm
Summarizing, you will need:
- A pharmacist in charge, he will be the authorized person to import.
- Importation Permits from the Pharmacy Board.
- Complete application of the GENERAL GUIDELINES and GROUP XI
GUIDELINES of the "GUIDELINES & PROCEDURES IN RELATION TO APPLICATIONS
FOR TRADE LICENCES" from Ministry of Health & Quality of Life.
- Import documents required by Customs.
The following association is registered at the NAPRA (National
Association of Pharmacy Regulatory Authorities) as the Pharmacy
Licensing Authority in Mauritius, I think that you will find valuable
info contacting them:
Société Pharmaceutique de l'Ile Maurice
P.O. Box 685
Bell Village, Republic of Mauritius
Tel.: +230-212-68 31/+230-212-59 32
Fax: +230-212-41 55
Email: kailash27@iutnet.mu
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Documentation:
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Mauritius - THE PHARMACY ACT - :
http://www.unodc.org/unodc/legal_library/mu/legal_library_1992-06-05_1992-17.html?print=yes
THE CONSUMER PROTECTION (PRICE AND SUPPLIES CONTROL) ACT:
"These regulations may be cited as the Consumer Protection (Control of
Imports) Regulations 1999."
Pharmaceutical products are included in the list of controlled goods
(First schedule) and there is also an Import Permit form application
sample (page 17 - regulation 5 (2)(b)).
See pages 1 to 5 for regulations on controlled goods.
http://www.mcci.org/Photos/document/annex3.pdf
"Health Clearance : Ministry of Health and Quality of Life"
http://www.boimauritius.com/Documents/doc35.doc
THE LOCAL GOVERNMENT ACT 2003:
http://localgovernment.gov.mu/download/lg_act.pdf
"The Mauritius Chamber of Commerce and Industry - Procedures for import":
http://www.mcci.org/IT_imports.htm
More documentation at "Government of Mauritius - ACTS":
http://ncb.intnet.mu/govt/acts.htm
Also navigate "The Mauritius Chamber of Commerce and Industry" website:
http://www.mcci.org/default.aspx
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As always I hope that this answer will be useful to your purposes.
Best regards.
livioflores-ga |
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