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Vista previa e impresión

Propiedades

Vista previa e impresión

Propiedades

Intera (15) arrow_drop_up arrow_drop_down
Register a medical product  (3) expand_more expand_less
Obtain export license for pharmaceutical products  (3) expand_more expand_less
Kugirana amasezerano n'uwunganira abandi muri Gasutamo  (1) expand_more expand_less
Guhabwa icyemezo cy'inkomoko y'ibicuruzwa muri EAC  (2) expand_more expand_less
Imenyekanisha ry'ibicuruzwa  (6) expand_more expand_less

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Incamake y'uko bigenda

ibigo bifitemo uruhare 8 expand_more expand_less

Banki ya Kigali (x 2)
Rwanda Food and Drugs Authority (x 2)
Pharmaceutical Regulatory Information Management system (x 2)
Umuntu wunganira abandi muri Gasutamo
e-Single Window (x 3)
Banki
Ishami rya Gasutamo rishinzwe Transit. Ibyoherezwa mu mahanga n'Ibiro byo ku mipaka (x 3)
Ishami rya Gasutamo - Ibiro bya Gatuna

Ibisubizo 5 expand_more expand_less

Certificate of medical product registration
Export license (FDA)
Amasezerano
Icyemezo cy'inkomoko mu bihugu bya EAC
Validated cargo manifest (C2)

Impapuro zisabwa expand_more expand_less

Urupapuro bishyuriraho muri banki (x 2)
Inyemezabwishyu (x 2)
Application letter - med registration
Application form - med registration
Icyemezo cy'isuzuma - (ibisubizo bya laboratwari)
Fagitire y'ibicuruzwa
Inyandiko iriho urutonde rw'imizigo n'ibirimo (x 4)
Import permit (Kenya pharmaceuticals)
Test report (certificate of analysis)
Icyemezo cy'iyandikwa rya sosiyete yo mu gihugu
Fagitire
Fagitire (x 2)
Export license (FDA)
Icyemezo cy'inkomoko mu bihugu bya EAC
Inyandiko y'isuzumwa - Ex 1
Kwemererwa kwishyura - imenyekanisha ryo kohereza ibicuruzwa hanze
Customs declaration from importing country
Imenyekanisha ryohereza ibicuruzwa hanze
Cargo manifest (C2)

Gereranya ikiguzi Amafaranga  428,000 +

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RWF expand_more expand_less
  • RWF Add Name Here
Iki ni ikigereranyo gihinduka bitewe n'uko ibicuruzwa byanyu bingana Barisha ikiguzi

Ikiguzi

Gereranya ikiguzi

Amafaranga 400,000
registration fee for human medicine
Amafaranga 25,000
export license fee
Amadolari 0 -
Amadolari  150 kuri buri imenyekanisha
Ibipimo by’ibihembo abunganira abandi muri Gasutamo baka, byo kubakorera imenyekanisha ry’ibicuruzwa no kubikurkirana muri Gasutamo kugeza bisohotse, bishyirwaho n’Ishyirahamwe Nyarwanda ry’Abunganira Abandi muri Gasutamo http://www.adrwanda.com/
Amafaranga 3,000
amafaranga yo gukora imenyekanisha kuri interineti
Amafaranga 0 -
Amafaranga  2,000 kuri buri kontineri
ibimenyetso by’umutekano bishyirwa kuri za kontineri no ku makanyo afungishwa ingufuri

Igihe cyose bimara 182iminsi - 279iminsi  expand_more expand_less

  Min. Max.
Igihe cyose bimara: 182iminsi 279iminsi
harimo:
Gutegereza ku murongo: 0mn 1h. 50mn
Aho babariza: 1h. 10mn 3h. 30mn
Igihe cyo gutegereza intera ikurikiyeho: 181iminsi 278iminsi

Amategeko 12 expand_more expand_less

The East African Community Customs Management Regulations, 2010 Amabwiriza ku imicungire ya za Gasutamo zo muri EAC, 2010
EAC Rules of origin 2015 Amategeko ya EAC agenga inkomoko y'ibicuruzwa 2015 (Ingingo ya 17)
Guidelines on submission of documentation for registration of human medicinal products FDA Guidelines on submission of documentation for registration of human medicinal products annex III-X
FDA Notice to the public - 20 March 2020 FDA Notice to the public - 20 March 2020
FDA Regulation Governing Registration of Medicinal Products FDA Regulation governing registration of medicinal products
  ingingo 1-14, 14-18
FDA Regulation governing service fees, tariff and fines FDA Regulation governing service fees, tariff and fines annex I
Guidance document on import control of health commodities Guidance document on import control of health commodities
Guidelines for importation and exportation of food Guidelines for importation and exportation of food
  Ingingo ya 1.3.10
Regional local clearing tariff Ibiciro byo kuzuza impapuro za Gasutamo mu karere no mu gihugu
East African Community Common External Tariff 2017 Igitabo cya EAC cy'Urutonde rw’Amahoro Rusange yakwa ku bicuruzwa bikomoka hanze y’Umuryango 2017
East African Community Customs Management Act   Itegeko rya EAC rigenga imicungire ya za Gasutamo z’Ibihugu bigize uwo Muryango
  Sections 75, 105
Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning
  ingingo 3, 8, 9
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