Jinsi ya kusajili dawa nje kwa NAFDAC katika Nigeria
Jinsi ya kusajili DRUG nje na NAFDAC NIGERIA
Lex Artifex LLP, sheria imara katika Nigeria, imeanzisha F&D Helpdesk kusaidia watu binafsi na makampuni ya kushiriki katika utengenezaji, usambazaji, usafirishaji na uingizaji wa umewekwa chakula na madawa ya kulevya bidhaa katika mkutano mahitaji yaliyowekwa na Shirika la Taifa la Nigeria kwa Chakula na Dawa na Udhibiti ("NAFDAC"). uchapishaji huu hutoa ufahamu wa jinsi ya kujiandikisha dawa nje kwa NAFDAC katika Nigeria.
JINSI YA KUOMBA kujiandikisha DRUG nje na NAFDAC NIGERIA
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Programu kusajili nje ya madawa ya kulevya bidhaa na NAFDAC katika Nigeria zinaweza kufanywa kwa njia ya wakala mtengenezaji, kuteuliwa kupitia Nguvu ya Mwanasheria au Mkataba Mkataba wa Viwanda (ambapo husika);
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Nguvu ya Mwanasheria ni kuwa notarized katika nchi ya asili na Notary Public;
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maombi kwa ajili ya usajili itakuwa ni pamoja na jina la mtengenezaji, jina generic, jina brand (ambapo husika), nguvu, dalili na taarifa zote zinazohitajika kwenye fomu kinachotakiwa;
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tofauti maombi fomu ni kuwasilishwa kwa kila bidhaa ya madawa ya kulevya kusajiliwa. Katika muktadha huu, bidhaa dawa ina maana uundaji tofauti ya madawa ya kulevya. Hata hivyo, maombi ya usajili wa moja fomu kipimo na uwezo tofauti itatolewa kwa kutumia fomu ya maombi tofauti.
nYARAKA
1. The manufacturer, katika kesi ya bidhaa kutoka nje ya madawa ya kulevya (kutoka India na China pekee), Lazima kuwasilisha ushahidi (Mtengenezaji Cheti) kwamba wao ni leseni ya utengenezaji dawa kwa ajili ya kuuza katika nchi ya asili. ushahidi hayo lazima iliyotolewa na Mamlaka ya Afya uwezo katika nchi ya utengenezaji.
2. There must be evidence that the drug product is manufactured according to Good Manufacturing Practice (GMP).
3. There must be evidence by the competent Health Authority that the sale of the product does not constitute a contravention of the drug laws of that country (yaani. Hati ya bidhaa Dawa (COPP) kwamba inajilainisha na WHO format).
· The documents in respect of 1-3 shall be authenticated by the Nigerian Mission in that country. In countries where no Nigerian Embassy or High Commission exists, nyingine yoyote Ubalozi au High Commission of Jumuiya ya Madola au West nchi yoyote ya Afrika inaweza kuthibitisha huo.
4. Two (2) dossiers itakuwa iliyowasilishwa alifanya nje kwa mujibu wa Shirika la format.
5. Ushahidi wa Biashara Mark kibali kwa ajili ya jina brand kutoka Wizara ya Shirikisho ya Biashara nchini Nigeria lazima kuwasilishwa.
6. Copy of current Annual Licence to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria should be submitted.
7. Copy of Current Certificate of Registration Retention of Premises issued by Pharmacists Council of Nigeria
8. Comprehensive Certificate of analysis of the batch of product submitted for registration processing shall be submitted.
PRODUCT
1. A drug product shall not be manufactured in Nigeria, isipokuwa kiwanda ni kukaguliwa na cheti cha Recognition ni iliyotolewa na NAFDAC.
2. In the case of an imported new drug substance, lazima kuna ushahidi kuwa mdogo wa ndani majaribio ya kliniki zimefanywa, na kwamba bidhaa hiyo imesajiliwa katika nchi ya asili na pia, katika angalau 2 au nchi zilizoendelea zaidi.
3. No combination drug product shall be registered or considered for registration unless there is proven evidence that such a product has clinical advantage over the single drug available for the same indication(s).
4. The application should indicate the class or type of registration required – kama dawa tu bidhaa au Zaidi ya Counter.
5. Product found to be of doubtful, kidogo au hakuna thamani ya matibabu wala kuchukuliwa kwa ajili ya usajili.
6. An applicant shall not be allowed to register a formulation in more than one brand name even where different doses of the active ingredient(s) hutumika.
7. All dosage forms of a particular brand name must contain the same active ingredient(s) au angalau kuu kazi ingredient(s)
k.m.. A cream – Betamethasone 10mg
sabuni – Betamethasone 20mg
LEBO
1. Labelling shall be informative, wazi na sahihi.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
a) Name of medicine (jina brand) inapotumika na jina generic.
b) Name and full location address of the manufacturer.
c) Provision for NAFDAC Registration Number on product label.
d) Batch No., tarehe ya viwanda na kumalizika tarehe. (e) Dosage form & nguvu
e) Indications, frequency, njia, hali ya utawala.
f) Dosage regimen on the package (OTC madawa ya kulevya tu kama hakuna kuandamana kipeperushi kuingiza.
g) Leaflet insert, kama dawa ya bidhaa na hospitali vifurushi.
h) Net content of product.
i) Quantitative listing of all the active ingredients per unit dose. (k) Adequate warnings where necessary.
3. Where a brand name is used, Lazima kuwepo na jina generic ambayo lazima wazi katika tabia, imeandikwa moja kwa moja chini ya jina brand mfano:-
Ventolin vidonge
"Salbutamol"
4. Any drug product whose name or package label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, wala kuchukuliwa kwa ajili ya usajili.
5. Any drug product which is labeled in a foreign language shall NOT kuchukuliwa kwa ajili ya usajili kama tafsiri ya Kiingereza ni pamoja na kwenye studio na mfuko kuingiza (ambapo husika).
Ushuru na gharama za usajili na NAFDAC
Kwa maelezo kuhusu ushuru husika na gharama kwa ajili ya chakula na usajili wa madawa ya kulevya nchini Nigeria, wasiliana nasi na maelezo au picha ya bidhaa(s) walitaka kusajiliwa, na tutakutumia makadirio gharama yoyote. Barua pepeatlexartifexllp40lexartifexllp.com, WhatsApp +234 803 979 5959.
Timeline
kalenda ya matukio kwa ajili ya usajili wa bidhaa kutoka kuwasilisha sampuli hadi utoaji wa nambari ya usajili ni mia (100) siku kazi. Hata hivyo, hii inategemea kufuata kuridhisha na mwombaji.