Import unapproved medicine into Tanzania

Mahitaji ya Kuagiza Dawa kwa Matumizi Binafsi Nchini Tanzania

Kulingana na taarifa zinazopatikana kuhusu Sheria ya Dawa na Vifaa Tiba ya Tanzania ya mwaka 2019, mtu anayehitaji kuagiza dawa ambayo haijaidhinishwa au haipatikani nchini Tanzania kwa matumizi binafsi, hasa kama dawa hiyo ni ya kuokoa maisha, anapaswa kufuata taratibu maalum zilizowekwa na Mamlaka ya Dawa na Vifaa Tiba (TMDA).

Kutuma Maombi kwa Mamlaka Husika

Mtu husika anashauriwa kuwasilisha ombi rasmi kwa TMDA ili kupata kibali cha kuagiza dawa hiyo. Ombi hilo linapaswa kujumuisha maelezo yafuatayo:

• Jina kamili la dawa na fomu yake ya upimaji.
• Kiasi cha dawa kinachohitajika.
• Madhumuni ya matumizi ya dawa hiyo.
• Uthibitisho wa hitaji la dawa hiyo kutoka kwa daktari aliyesajiliwa nchini Tanzania.
• Maelezo ya mtengenezaji na msambazaji wa dawa hiyo nje ya nchi.

Kwa taarifa zaidi, inashauriwa kutembelea tovuti ya Mamlaka ya Dawa na Vifaa Tiba (TMDA) au kuwasiliana nao moja kwa moja.

Ushahidi wa Hitaji la Matibabu

Mgonjwa anapaswa kuwasilisha barua kutoka kwa daktari wake inayoelezea umuhimu wa dawa hiyo kwa afya yake na kukosekana kwa mbadala ndani ya nchi. Barua hiyo inapendekezwa kujumuisha:

• Utambuzi wa ugonjwa.
• Sababu za kutumia dawa hiyo maalum.
• Tathmini ya hatari na manufaa ya matumizi ya dawa iliyoombwa.

Kutii Sheria na Kanuni za Usalama

Dawa inayoagizwa inapaswa kutimiza viwango vya ubora na usalama vinavyokubalika. TMDA inaweza kuhitaji nyaraka za ziada kama vile:

• Cheti cha uchambuzi kutoka kwa mtengenezaji.
• Ripoti ya tathmini ya hatari ya dawa hiyo.
• Nyaraka za usajili kutoka nchi nyingine ikiwa dawa hiyo imesajiliwa kwingine.

Usafirishaji na Utoaji wa Dawa

Baada ya kupata kibali kutoka TMDA, mgonjwa anapaswa kuhakikisha kuwa dawa inasafirishwa kwa njia salama. Inashauriwa kwamba dawa isafirishwe moja kwa moja kwa mgonjwa au kupitia taasisi ya afya inayotambulika. Kwa maelekezo zaidi, tembelea taratibu za uagizaji na usafirishaji wa dawa.

Vikwazo na Masharti

Ni muhimu kutambua kuwa TMDA inaweza kukataa ombi endapo dawa hiyo itaonekana kuwa si salama kwa matumizi ya binadamu au kama kuna hatari ya matumizi mabaya. Aidha, kiasi cha dawa kinachoruhusiwa kinaweza kuwekewa kikomo kulingana na mahitaji ya mgonjwa kwa kipindi maalum.

Hitimisho

Kuagiza dawa isiyopatikana au isiyoidhinishwa nchini Tanzania kwa matumizi binafsi kunahitaji kufuata taratibu zilizowekwa ili kuhakikisha usalama na ufanisi wa dawa hiyo. Ni muhimu kuwasiliana na TMDA na kupata ushauri wa kitaalam ili kufanikisha mchakato huu.

Rejea

• Mamlaka ya Dawa na Vifaa Tiba Tanzania (TMDA)
• Uagizaji na Usafirishaji wa Dawa na Vifaa Tiba
• Sheria na Kanuni za TMDA

Wersja angielska

Requirements for Importing Medicine for Personal Use into Tanzania

Based on available information regarding the Tanzania Medicines and Medical Devices Act of 2019, an individual who needs to import a medicine that is unapproved or unavailable in Tanzania for personal use, especially if the medicine is life-saving, is advised to follow specific procedures set by the Tanzania Medicines and Medical Devices Authority (TMDA).

Submitting an Application to the Relevant Authority

The individual is encouraged to submit a formal application to the TMDA to obtain permission to import the medicine. This application should include the following details:

• The full name of the medicine and its dosage form.
• The quantity of medicine required.
• The purpose of using the medicine.
• Proof of the need for the medicine from a registered medical practitioner in Tanzania.
• Details of the manufacturer and supplier of the medicine abroad.

For more information, it is recommended to visit the TMDA website or contact them directly.

Evidence of Medical Necessity

The patient should provide a letter from their doctor outlining the importance of the medicine for their health and the unavailability of alternatives within the country. The letter is suggested to include:

• The diagnosis of the medical condition.
• The reasons for needing that specific medicine.
• An assessment of the risks and benefits of using the requested medicine.

Compliance with Safety Regulations

The imported medicine must meet acceptable quality and safety standards. The TMDA may require additional documentation such as:

• A certificate of analysis from the manufacturer.
• A risk assessment report of the medicine.
• Registration documents from other countries if the medicine is registered elsewhere.

Transportation and Delivery of the Medicine

After obtaining approval from the TMDA, the patient should ensure that the medicine is transported safely. It is advised that the medicine be shipped directly to the patient or through a recognized health institution. For further guidelines, visit the import and export procedures for medicines.

Restrictions and Conditions

It is important to note that the TMDA may reject the application if the medicine is deemed unsafe for human use or poses a risk of misuse. Additionally, the quantity permitted for importation may be limited based on the patient's needs for a specific period.

Wnioski

Importing an unapproved or unavailable medicine into Tanzania for personal use requires adherence to established procedures to ensure the safety and efficacy of the medicine. It is essential to liaise with the TMDA and seek professional advice to successfully navigate this process.

Referencje

• Tanzania Medicines and Medical Devices Authority (TMDA)
• Import and Export of Medicines and Medical Devices
• TMDA Laws and Regulations