Carane kanggo ndhaftar tamba diimpor karo NAFDAC ing Nigeria
CARA DAFTARNE obat-obatan diimpor WITH NAFDAC IN NIGERIA
Lex Artifex LLP, tenan hukum Nigeria, wis ngenalaken F&D Helpdesk ngewangi individu lan perusahaan melu ing Manufaktur, distribusi, ekspor lan importation produk panganan lan obat-obatan diatur ing patemon ing syarat Nyetel dening Nasional Nigeria kang Food lan tamba Administration lan Control ("NAFDAC"). Publikasi iki menehi pemahaman carane kanggo ndhaftar tamba diimpor karo NAFDAC ing Nigeria.
CARA aplikasi TO DAFTARNE obat-obatan diimpor WITH NAFDAC IN NIGERIA
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Aplikasi kanggo ndhaftar produk tamba diimpor karo NAFDAC ing Nigeria bisa digawe liwat agen a produsen, dados liwat Power of Attorney utawa Agreement Contract Manufacturing (diperlokaké);
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The Power of Attorney iku bakal Notarized ing negara asal dening Public Notaris;
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Aplikasi kanggo Pendhaftaran bakal kalebu jeneng Produsèn, jeneng umum, jeneng merek (diperlokaké), kekuatan, indikasi lan kabeh informasi sing dijaluk ing formulir diwènèhaké;
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A wangun aplikasi kapisah kanggo diajukake kanggo saben produk tamba kanggo pangguna. Ing konteks iki, produk tamba tegese ngrumusake tamba kapisah. Nanging, aplikasi kanggo gratis saka siji wangun dosis karo beda kekiyatan bakal digawe ing wangun aplikasi kapisah.
DOCUMENTATION
1. The manufacturer, ing cilik saka produk tamba diimpor (saka India lan China mung), kudu ngirim bukti (Produsen Certificate) sing lagi dilisensi Pabrik obatan kanggo Advertisement ing negara asal. Kuwi bukti kudu ditanggepi dening panguwasa Health ing wewenang ing negara Pabrik.
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.. Certificate of Product Pharmaceutical (COPP) sing sesuai 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, sembarang Embassy utawa High liyane Komisi sembarang Commonwealth utawa West negara Afrika bisa keasliane padha.
4. Two (2) dossiers bakal diajukake digawe metu ing sesuai karo format Agensi kang.
5. Bukti Trade Mark persetujuan kanggo jeneng account saka Federal Kamentrian Perdagangan ing Nigeria kudu diajukake.
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, kajaba pabrik wis dititi prikso lan Certificate of Recognition ditanggepi dening NAFDAC.
2. In the case of an imported new drug substance, ana kudu bukti sing ngancani lokal winates wis di tangani, lan sing kuwi produk kadhaftar ing negara asal lan uga, ing paling 2 utawa negara liyane dikembangaké.
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 – apa resep mung produk utawa Swara Counter ing.
5. Product found to be of doubtful, sethitik utawa ora Nilai babagan pengobatan bakal ora bisa dianggep kanggo Pendhaftaran.
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) digunakake.
7. All dosage forms of a particular brand name must contain the same active ingredient(s) utawa ing paling aktif utama(s)
E.g. A cream – Betamethasone 10mg
A sinetron – Betamethasone 20mg
Labeling
1. Labelling shall be informative, langit lan akurat.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
a) Name of medicine (jeneng merek) diperlokaké lan jeneng umum.
b) Name and full location address of the manufacturer.
c) Provision for NAFDAC Registration Number on product label.
d) Batch No., tanggal Manufacturing lan Tanggal kedaluwarsa. (e) Dosage form & kekuatan
e) Indications, frekuensi, rute, kondisi administrasi.
f) Dosage regimen on the package (obatan OTC mung yen ana insert Brosur gawan.
g) Leaflet insert, yen resep produk lan rumah sakit ngemas.
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, ana kudu dadi jeneng umum kang arep lewat ing karakter, ditulis langsung ing jeneng account contone:-
tablet VENTOLIN
"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, bakal ora bisa dianggep kanggo Pendhaftaran.
5. Any drug product which is labeled in a foreign language shall ora dianggep kanggo Pendhaftaran kajaba lan agensi Inggris kalebu ing label lan paket insert (diperlokaké).
Tariffs lan biaya OF gratis WITH NAFDAC
Kanggo informasi ing tariffs ditrapake lan biaya kanggo pangan lan Pendhaftaran tamba ing Nigeria, hubungi kita karo gambaran utawa gambar prodhuk(s) sought kanggo pangguna, lan kita bakal ngirim prakiran biaya kanggo sampeyan. Email ing lexartifexllp@lexartifexllp.com, Tampilan +234 803 979 5959.
timeline
Ing timeline produk gratis saka pengajuan saka conto nganti ditokake saka nomer registrasi atus (100) dina karya. Nanging, iki gumantung ing selaras puas dening pelamar.