Import unapproved medicine into Mauritius

Importing medicines into Mauritius

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Ki Bizwen Pou Amenn Medsin pou Itilizasyon Pèsonel Moris

Selon "Mauritius Health Products Regulatory Authority Act" (2017), importasyon medsin ki pa aprouve ou ki pa disponib Moris, me ki neseser pou sove lavi, li kapav fer ar serten kondisyon. Sa prosedir-la existe pou asire ki bann pasian gagn akse ar tretman neseser kan zot pa trouv lokalman.

Importasyon pou Itilizasyon Pèsonel

Amenn medsin pou itilizasyon pèsonel vedir ki medsin-la pou servi zis par sa individi ki pe fer demann-la. Li pa pou revann ou distribie ar lezot. Sa prensip-la enportan pou asir itilizasyon korek ek pou evit abiz sibstans medikal.

Demann Permi D'importasyon

Pou inisye prosedir-la, individi bizwen soumet enn demann formel ar Mauritius Health Products Regulatory Authority (MHPRA). Demann-la bizwen fer avan ki medsin-la antre dan pei. Sa permet lotorite evalye bann ris ek benefis asosie ar importasyon sa medsin-la.

Dokiman Neseser

Demann-la bizwen akonpagne par bann dokiman swivan:

Preskripsion Medikal: Enn preskripsion resan depi enn dokter akredite ki montre ki medsin-la neseser pou tretman pasian.
Rapor Medikal Detaye: Detay lor kondisyon medikal pasian ek kifer medsin-la esansiel pou so tretman.
Detay lor Medsin: Enklizion nom komersial, nom jenerek, kompozision, dozaz, ek mwayen administrasyon.
Sertifika Analiz: Si posib, fourni enn sertifika depi fabrikan ki atest kalite ek sekirite medsin-la.

Prosesis Evalyasion

Apre soumision, MHPRA pou fer enn evalyasion aprofondi pou asire:

Nesesite Medsin-la: Verifie si medsin-la esansiel ek si okenn altarnativ disponib lokalman.
Ris ek Sekirite: Analiz bann ris potansiel asosie ar itilizasyon medsin-la.
Sekirite Piblik: Asire ki importasyon pe pa menas sante piblik.

Delivrans Permi

Si demann-la aprouve, MHPRA pou emet enn permisyon ek donn bann kondisyon spesifik pou importasyon. Individi bizwen respekte tou kondisyon pandan prosedir importasyon ek itilizasyon medsin-la.

Taks ek Fre Asosie

Importasyon medsin kapav soumet a taks ek fre. Konsilte Mauritius Revenue Authority (MRA) pou gagn detay lor bann fre ek prosedir peyman.

Restriksion lor Bann Sibstans Kontrole

Medsin ki kontenir bann sibstans kontrole (par exanp, narkotik ou psychotropik) nesesit enn permisyon adisionel depi lotorite konserne. Violation bann regleman kapav amene a sanksion sever ek aksi legal.

Konsekans Non-Konformite

Pa respekte bann prosedir kapav ena konsekans grav:

Sezisman Medsin: Lotorite kapav konfiske medsin improte ilegalman.
Sanksyon Légal: Individi kapav fer fas a lamann, poursit penal, ou mem prizon.
Ris pou Lasante: Medsin pa verifie kapav koz domaz grav ar lasante.

Konsiltasion Avek Profesionel Lasante

Li rekomande pou konsilte enn profesionnèl lasante ou dokter spesialize pou gagn konsey lor bann demars ek altarnativ posib.

Etap Pou Swiv

Konsilte ou dokter pou konfirme nesesite medsin-la.
Reini tou dokiman neseser pou soutenir ou demann.
Soumet enn demann ek dokiman ar MHPRA.
Atann evalyasion ek rezilta depi MHPRA.
Si aprouve, swiv bann kondisyon pou importasyon.
Konsilte MRA pou bann taks ek fre.

Kontakt Detay MHPRA

Pou plis ransegnman ou lasistans, ou kapav kontakte MHPRA:

Adres: 35, rue Emmanuel Anquetil, Port-Louis, Maurice
Telefonn: +230 202 0500
Email: [email protected]
Sitweb: https://mhpra.govmu.org/

Rol MHPRA

MHPRA responsab pou reglemantasyon ek kontrol bann prodwi santi, enkli medsin ek aparatus medikal. Zot asire ki tou prodwi ki rant dan pei satisfer bann norm kalite ek sekirite internasyonal.

Konesans Lalwa ek Responsabilite Individiel

Li enportan ki tou dimoun pran konesans bann lalwa ek regleman konsernan importasyon medsin. Responsabilite li lor individi pou asire ki zot an konformite avek lalwa pou protez zot prop lasante ek sa lezot.

Referans

English version

Requirements for Importing Medicine for Personal Use into Mauritius

According to the "Mauritius Health Products Regulatory Authority Act" (2017), importing unapproved or unavailable medicine into Mauritius for personal use is possible under specific conditions, especially if the medicine is life-saving. This procedure exists to ensure that patients have access to necessary treatments when they are not available locally.

Importation for Personal Use

Importing medicine for personal use means that the medicine will be used solely by the individual making the request. It is not intended for resale or distribution to others. This principle is important to ensure proper usage and to prevent the abuse of medical substances.

Application for Import Permit

To initiate the process, the individual must submit a formal application to the Mauritius Health Products Regulatory Authority (MHPRA). The application must be made before the medicine enters the country. This allows the authority to evaluate the risks and benefits associated with importing the medicine.

Required Documentation

The application must be accompanied by the following documents:

Medical Prescription: A recent prescription from a registered medical practitioner indicating that the medicine is necessary for the patient's treatment.
Detailed Medical Report: Details about the patient's medical condition and why the medicine is essential for their treatment.
Medicine Details: Including brand name, generic name, composition, dosage, and method of administration.
Certificate of Analysis: If possible, provide a certificate from the manufacturer attesting to the quality and safety of the medicine.

Evaluation Process

Upon submission, the MHPRA will conduct a thorough evaluation to ensure:

Necessity of the Medicine: Confirm if the medicine is essential and if any alternatives are available locally.
Risks and Safety: Analyze potential risks associated with the use of the medicine.
Public Safety: Ensure that the importation does not threaten public health.

Issuance of Permit

If the application is approved, the MHPRA will issue a permit and provide specific conditions for importation. The individual must comply with all conditions during the importation process and use of the medicine.

Associated Taxes and Fees

Importing medicine may be subject to taxes and fees. Consult the Mauritius Revenue Authority (MRA) to obtain details on costs and payment procedures.

Restrictions on Controlled Substances

Medicines containing controlled substances (e.g., narcotics or psychotropics) require additional authorization from the relevant authority. Violations of regulations may lead to severe sanctions and legal action.

Consequences of Non-Compliance

Failing to adhere to procedures can have serious consequences:

Seizure of Medicine: Authorities may confiscate illegally imported medicines.
Legal Sanctions: Individuals may face fines, prosecution, or even imprisonment.
Health Risks: Unverified medicines can cause serious health damage.

Consultation with Healthcare Professionals

It is recommended to consult a healthcare professional or specialist to obtain advice on procedures and possible alternatives.

Steps to Follow

Consult your doctor to confirm the necessity of the medicine.
Gather all necessary documentation to support your application.
Submit the application and documents to the MHPRA.
Await evaluation and decision from the MHPRA.
If approved, follow the conditions for importation.
Consult the MRA for taxes and fees.

Contact Details of MHPRA

For more information or assistance, you can contact the MHPRA:

Address: 35, Emmanuel Anquetil Street, Port Louis, Mauritius
Phone: +230 202 0500
Email: [email protected]
Website: https://mhpra.govmu.org/

Role of the MHPRA

The MHPRA is responsible for the regulation and control of health products, including medicines and medical devices. They ensure that all products entering the country meet international quality and safety standards.

Understanding the Law and Individual Responsibility

It is important for everyone to be aware of the laws and regulations regarding the importation of medicines. The responsibility lies with the individual to ensure compliance with the law to protect their health and that of others.

References

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