How to register an imported drug with NAFDAC in Nigeria HOW TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA Lex Artifex LLP, 'chompanaidh lagh ann an Nigeria, a-steach an F&D Helpdesk a 'cuideachadh dhaoine fa leth agus companaidhean an sàs ann an saothrachadh, sgaoileadh, exportation agus a bhith toirt a riaghladh biadh agus stuthan drogaichean ann an coinneachadh ri na riatanasan air an suidheachadh le Nigeria buidheann nàiseanta airson biadh agus Dhrugaichean Rianachd agus Smachd ("NAFDAC"). Tha am foillseachadh seo a 'toirt fradharc air mar a chlàradh a-steach dhrogaichean le NAFDAC ann an Nigeria. HOW TO APPLY TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA Application to register an imported drug product with NAFDAC in Nigeria can be made by the manufacturer or through his agent, appointed through a Power of Attorney or Contract Manufacturing Agreement (where applicable); The Power of Attorney is to be notarized in the country of origin by a Notary Public; Tha iarrtas airson clàradh a-steach bithidh an ainm an Dèanadair, ainm gnèitheach, brand name (where applicable), neart, comharraidhean agus a h-uile fiosrachadh riatanach air an òrdachadh foirmean; A fa leth foirm-iarrtais gu bhith air a chur a-steach airson gach bathar dhrogaichean a bhith clàraichte. Ann an cho-theacsa seo, dhrogaichean a bhathar a 'ciallachadh air leth dhrogaichean cruthachadh. However, an tagradh airson clàradh aon dosage foirm le diofar neartan bithidh a dhèanamh air leth a foirm-iarrtais. sgrìobhainnean 1. The manufacturer, ann an cùis-steach bathar dhrogaichean (bho na h-Innseachan agus ann an Sìona a-mhàin), Feumaidh fianais a-steach (Dèanamh Teisteanas) a tha iad a 'dèanamh dhrogaichean cead airson a reic anns an dùthaich tùs. Feumaidh fianais a leithid chur a-mach le Ùghdarras Slàinte comasach ann an dùthaich dèanamh. 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 (i.e.. Teisteanas leigheis Mhic a Product (COPP) that conforms to 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, sam bith eile an Ambasaid no Àrd-Coimisean sam bith a 'Cho-fhlaitheis no West African dùthaich urrainn dearbhadh aon. 4. The applicant shall submit two (2) dossiers made out in accordance with the Agency’s format. 5. Evidence of Trade Mark Approval for brand name from Federal Ministry of Commerce in Nigeria should be submitted. 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. BHATHAR 1. A drug product shall not be manufactured in Nigeria, mura h-eil an fhactaraidh a sgrùdadh agus Teisteanas Aithne ga thoirt seachad le NAFDAC. 2. In the case of an imported new drug substance, an sin feumaidh e bhith gu bheil an fhianais chuingealaichte ionadail deuchainnean clionaigeach air a bhith air a ghabhail os làimh, agus gu bheil leithid de bhathar a tha clàraichte ann an dùthaich tùs agus cuideachd a ', ann an co-dhiù 2 no barrachd dhùthchannan leasaichte. 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 - whether a prescription only product or Over the Counter. 5. Product found to be of doubtful, nach eil mòran luach leigheasail Cha tèid beachdachadh airson clàradh. 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) Thathar a 'cleachdadh. 7. All dosage forms of a particular brand name must contain the same active ingredient(s) no co-dhiù a 'phrìomh ghrìtheid a gnìomhach(s) E.g. A cream - Betamethasone 10mg A soap - Betamethasone 20mg LABainm a bhuineadh Labelling shall be informative, soilleir agus pongail. 2. Minimum requirements on the package label in accordance with the drug labeling regulations should be: a) Name of medicine (brand name) far a bheil e iomchaidh agus ainm gnèitheach. b) Name and full location address of the manufacturer. c) Provision for NAFDAC Registration Number on product label. d) Batch No., Manufacturing ceann-latha agus ceann-là Crìche. (S) Dosage form & strength e) Indications, tricead, slighe, na h-rianachd. f) Dosage regimen on the package (OTC drogaichean a-mhàin mura h-eil an cois a 'bhileag cuir a-steach. g) Leaflet inserts ma òrdugh bathar is ospadal pasgain. 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, Feumaidh an ainm gnèitheach a bu chòir a bhith follaiseach ann an caractar, sgrìobhte dìreach fo ainm m.e.:- VENTOLIN TABLETS “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, Cha tèid far a bheil iomchaidhson clàradh. 5. Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable). TARIFF All tariffs are as prescribAchMELINE The timeline for product registration from submission of samples up to the issuance of the registration number is hundred (100) work days. However, seo an crochadh air riarachail gèilleadh leis an tagraiche. PUINGEAN CUDROMACH GU AIRE 1. Registration of a product does not automatically confer Advertising permit. A separate approval by the Agency shall be required if the product is to be advertised. 2. NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from the Agency. 3. NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period. 4. Filling an application form or paying for an application form does not confer registration status. 5. Failure to respond promptly (withiobair làithean days) to queries on enquiries raised on the application, will automatically lead to suspension of further processing of the application. 6. A successful application attracts a Certificate of Registration with a validity period of five (5) bliadhna. ABOUT LEX ARTIFEX LLP Lex Artifex LLP is the window for manufacturers, às-mhalairtearan, agus sgaoilidh riaghlaichte biadh agus drogaichean a 'sireadh stuthan ceadachd ann an Nigeria agus a' sireadh ruigsinneachd air a 'mhargaidh Nigerian. We are a one-stop shop for legal compliance and due diligence services in Nigeria. Bidh sinn a’ toirt stiùireadh laghail do luchd-cleachdaidh tro gach ceum den phròiseas malairt agus nas fhaide air falbh. To learn more about the Lex Artifex LLP's F&D Helpdesk and how we can help you with the registration of your pharmaceutical products in Nigeria, cuir post-d: lexartifexllp@lexartifexllp.com; ghairm +234.803.979.5959.

Ciamar a chlàradh a-steach dhrogaichean le NAFDAC ann an Nigeria

MAR A chlàradh a-steach DHROGAICHEAN WITH NAFDAC ann an Nigeria

Lex Artifex LLP, 'chompanaidh lagh ann an Nigeria, a-steach an F&D Helpdesk a 'cuideachadh dhaoine fa leth agus companaidhean an sàs ann an saothrachadh, sgaoileadh, exportation agus a bhith toirt a riaghladh biadh agus stuthan drogaichean ann an coinneachadh ri na riatanasan air an suidheachadh le Nigeria buidheann nàiseanta airson biadh agus Dhrugaichean Rianachd agus Smachd ("NAFDAC"). Tha am foillseachadh seo a 'toirt fradharc air mar a chlàradh a-steach dhrogaichean le NAFDAC ann an Nigeria.

MAR A 'BUNTAINN RI chlàradh a-steach DHROGAICHEAN WITH NAFDAC ann an Nigeria

  • Iarrtas gus clàradh a-steach an dhrogaichean bathar le NAFDAC ann an Nigeria a dhèanamh tro dèanamh àidseant, fhastadh tro Cumhachd-ionaid no Cùmhnant Aonta Manufacturing (far a bheil iomchaidh);
  • The Power-ionaid gu bhith air a notarized ann an dùthaich thùs le Notary Phoblach;
  • Tha iarrtas airson clàradh a-steach bithidh an ainm an Dèanadair, ainm gnèitheach, ainm a bhuineadh (far a bheil iomchaidh), neart, comharraidhean agus a h-uile fiosrachadh riatanach air an òrdachadh foirmean;
  • A fa leth foirm-iarrtais gu bhith air a chur a-steach airson gach bathar dhrogaichean a bhith clàraichte. Ann an cho-theacsa seo, dhrogaichean a bhathar a 'ciallachadh air leth dhrogaichean cruthachadh. Ach, an tagradh airson clàradh aon dosage foirm le diofar neartan bithidh a dhèanamh air leth a foirm-iarrtais.

sgrìobhainnean

1. The manufacturer, ann an cùis-steach bathar dhrogaichean (bho na h-Innseachan agus ann an Sìona a-mhàin), Feumaidh fianais a-steach (Dèanamh Teisteanas) a tha iad a 'dèanamh dhrogaichean cead airson a reic anns an dùthaich tùs. Feumaidh fianais a leithid chur a-mach le Ùghdarras Slàinte comasach ann an dùthaich dèanamh.
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 (i.e.. Teisteanas leigheis Mhic a Product (COPP) a 'co-fhreagairt CÒ Inneal a 'Chlàir).
· 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, sam bith eile an Ambasaid no Àrd-Coimisean sam bith a 'Cho-fhlaitheis no West African dùthaich urrainn dearbhadh aon.
4. Two (2) dossiers bithidh a chur a-mach a dhèanamh ann na co-rèir ris a 'Bhuidhinn Inneal a' Chlàir.
5. Fianais Malairt Mark Aontachaidh airson ainm bho Fheadarail Ministrealachd na Malairt ann an Nigeria a bu chòir a chur a-steach.
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.

BHATHAR

1. A drug product shall not be manufactured in Nigeria, mura h-eil an fhactaraidh a sgrùdadh agus Teisteanas Aithne ga thoirt seachad le NAFDAC.
2. In the case of an imported new drug substance, an sin feumaidh e bhith gu bheil an fhianais chuingealaichte ionadail deuchainnean clionaigeach air a bhith air a ghabhail os làimh, agus gu bheil leithid de bhathar a tha clàraichte ann an dùthaich tùs agus cuideachd a ', ann an co-dhiù 2 no barrachd dhùthchannan leasaichte.
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 – co-dhiù a òrdugh a-mhàin bathar no Thairis air na Counter.
5. Product found to be of doubtful, nach eil mòran luach leigheasail Cha tèid beachdachadh airson clàradh.
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) Thathar a 'cleachdadh.
7. All dosage forms of a particular brand name must contain the same active ingredient(s) no co-dhiù a 'phrìomh ghrìtheid a gnìomhach(s)
E.g. A cream – Betamethasone 10mg
A siabann – Betamethasone 20mg

Ainmeachadh

1. Labelling shall be informative, soilleir agus pongail.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
a) Name of medicine (ainm a bhuineadh) far a bheil e iomchaidh agus ainm gnèitheach.
b) Name and full location address of the manufacturer.
c) Provision for NAFDAC Registration Number on product label.
d) Batch No., Manufacturing ceann-latha agus ceann-là Crìche. (S) Dosage form & neart
S) Indications, tricead, slighe, na h-rianachd.
f) Dosage regimen on the package (OTC drogaichean a-mhàin mura h-eil an cois a 'bhileag cuir a-steach.
g) Leaflet insert, ma òrdugh bathar is ospadal pasgain.
s) 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, Feumaidh an ainm gnèitheach a bu chòir a bhith follaiseach ann an caractar, sgrìobhte dìreach fo ainm m.e.:-
VENTOLIN tablaidean
"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, Cha tèid beachdachadh airson clàradh.
5. Any drug product which is labeled in a foreign language shall NOT bhith a 'beachdachadh airson clàradh mur eadar-theangachadh Beurla ghabhail a-steach air a' phacaid agus pasgan cuir a-steach (far a bheil iomchaidh).

Cìsean agus cosgais CLÀRADH WITH NAFDAC

Airson fiosrachadh air na iomchaidh taraifean agus cosgais airson biadh agus drogaichean clàradh ann an Nigeria, cuir fios thugainn le an tuairisgeul no dealbh a 'bhathar(s) sireadh a bhith clàraichte, agus cuiridh sinn na tuairmsean cosgais a tha thu. Email at lexartifexllp@lexartifexllp.com, WhatsApp +234 803 979 5959.

Loidhne-tìm

Tha an loidhne-tìm airson bathar clàradh bho tagradh de shampaill suas gu issuance an àireamh-chlàraidh 'S e cheud (100) obair làithean. Ach, seo an crochadh air riarachail gèilleadh leis an tagraiche.

 

MU Lex ARTIFEX LLP

Lex Artifex LLP, gnìomhachais agus malairteach air a 'chompanaidh lagh ann an Nigeria, 'S e an uinneig airson luchd-saothrachaidh, às-mhalairtearan, agus sgaoilidh riaghlaichte biadh agus drogaichean a 'sireadh stuthan ceadachd ann an Nigeria agus a' sireadh ruigsinneachd air a 'mhargaidh Nigerian. Tha sinn a 'bùth aon-stad airson gèillidh laghail agus dìchioll air sgàth seirbheisean ann an Nigeria. Bidh sinn a’ toirt stiùireadh laghail do luchd-cleachdaidh tro gach ceum den phròiseas malairt agus nas fhaide air falbh.
Airson tuilleadh ionnsachadh mu na Lex Artifex LLP Biadh & dhrugaichean (F&D) Helpdesk agus mar a tha sinn a 'tabhann riochdachadh dhut ann an Nigeria, cuir post-d: lexartifexllp@lexartifexllp.com; fòn no WhatsApp +234.803.979.5959.