Nigeriyada NAFDAC bilan import dori ro'yxatdan qanday
Nigeriya NAFDAC BILAN import dori reestriga QANDAY
Lex Artifex LLP, Nigeriyada huquq firmasi, F joriy etdi&D Qo'llab-quvvatlash xizmati ishlab chiqarish bilan shug'ullanuvchi shaxslar va kompaniyalar yordam berish, taqsimlash, Oziq-ovqat va farmatsevtika idorasi va nazorat qilish Nigeriyaning Milliy agentligi tomonidan belgilangan talablarni qondirish olib ketish va tartibga oziq-ovqat va dori mahsulotlarini chetdan ("NAFDAC"). Bu nashr Nigeriyada NAFDAC bilan import dori ro'yxatdan uchun qanday fikr-mulohazalarini beradi.
QANDAY Nigeriya NAFDAC BILAN import dori reestriga ARIZA UChUN
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Nigeriyada NAFDAC bilan import dori mahsulotni ro'yxatdan uchun Application bir ishlab chiqaruvchining vakili orqali amalga oshirilishi mumkin, a orqali tayinlandi Vakolatnoma yoki Buyurtmaga tayyorlash Shartnoma (qaerda qo'llaniladigan);
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Vekaletname bir chiqish mamlakatda notariusdan tasdiqlatib kerak Davlat notariusi;
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ro'yxatdan o'tkazish uchun ariza ishlab chiqaruvchi nomini o'z ichiga oladi, umumiy nomi, brendning nomi (qaerda qo'llaniladigan), kuch, belgilangan shakllari haqida ko'rsatmalar va barcha zarur axborot;
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Alohida ariza har bir dori mahsulot uchun ro'yxatdan o'tgan bo'lishi taqdim etiladi. Shu ma'noda, bir dori mahsulot alohida dori sudga anglatadi. ammo, turli kuchli bir doza shaklda ro'yxatga olish uchun ariza alohida ariza amalga oshiriladi.
HUJJATLARI
1. The manufacturer, import dori mahsulotlari taqdirda (Hindiston va Xitoy faqat), dalillarni taqdim etishlari shart (Ishlab chiqaruvchining guvohnoma) ular kelib chiqqan mamlakatda sotuvga narkotik ishlab chiqarish uchun litsenziyaga ega ekanligini. Bunday dalillar ishlab chiqarish mamlakatimizda vakolatli Sog'liqni saqlash organi tomonidan berilgan bo'lishi kerak.
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 (aytganda. Dori guvohnoma (COPP) deb mos JSST 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, har qanday Hamdo'stlik yoki G'arbiy Afrika mamlakat boshqa har qanday Elchixonasi yoki High komissiyasi bir xil autentifikatsiya mumkin.
4. Ikki (2) taqdim etilgan Fayl agentlik formatda muvofiq tayyorlangan taqdim etiladi.
5. markasi uchun savdo Mark tasdiqlash dalillar Nigeriyada Savdo federal vazirligi tomonidan taqdim etilgan bo'lishi kerak.
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, zavod tekshiriladi va tan guvohnoma NAFDAC tomonidan chiqarilgan bo'lsa,.
2. In the case of an imported new drug substance, cheklangan mahalliy klinik sinovlar amalga oshirildi, deb dalil bo'lishi kerak, va bunday mahsulot, shuningdek, kelib chiqishi va mamlakatda ro'yxatga olingan, kamida 2 yoki undan ko'p rivojlangan mamlakatlar.
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 – a bo'lsin aytish faqat Peshtaxtasi ustiga mahsulot yoki.
5. Product found to be of doubtful, kam yoki yo'q davolash qiymati ro'yxatga olish uchun qabul qilinmaydi.
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) ishlatiladi.
7. All dosage forms of a particular brand name must contain the same active ingredient(s) yoki kamida yirik faol topgan(s)
masalan,. A cream – Betamethasone 10mg
A sovun – Betamethasone 20mg
ETIKETLEME
1. Labelling shall be informative, aniq va to'g'ri.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
a) Name of medicine (brendning nomi) qaerda amaldagi va umumiy nomi.
b) Name and full location address of the manufacturer.
c) Provision for NAFDAC Registration Number on product label.
d) Batch No., Ishlab chiqarish va so'nggi foydalanish sana. (e) Dozalash shakli & kuch
e) Indications, chastota, yo'l, ma'muriyati shartlari.
f) Dosage regimen on the package (Birjadan tashqari dorilar hech kuzatuvchi varaqa Insert bor faqat.
g) Leaflet insert, retsept mahsulot va shifoxona paketlarni bo'lsa.
h) Net content of product.
men) Quantitative listing of all the active ingredients per unit dose. (k) Adequate warnings where necessary.
3. Where a brand name is used, xarakterini taniqli bo'lishi kerak umumiy nomi bo'lishi kerak, masalan markasi ostida to'g'ridan-to'g'ri yozilgan:-
Cialis TABLETKALARNING
"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, ro'yxatga olish uchun qabul qilinmaydi.
5. Any drug product which is labeled in a foreign language shall EMAS ingliz tarjima yorliq va prospektüsün kiritilgan bo'lsa, ro'yxatga olish uchun qabul qilinadi (qaerda qo'llaniladigan).
Tarif va NAFDAC BILAN ro'yxatga olish qiymati
amaldagi tariflar haqida ma'lumot va Nigeriyada oziq-ovqat va dori ro'yxatga olish uchun qiymati uchun, mahsulot ta'rifi yoki tasvir bilan bizga murojaat(s) ro'yxatga xohladi, va biz sizga iqtisodiy bashorat yuboradi. lexartifexllp@lexartifexllp.com da elektron pochta, WhatsApp +234 803 979 5959.
YILNOMANGIZ
namunalarini taqdim yuqoriga Ro'yxatdan soni berish uchun mahsulot ro'yxatga olish uchun Timeline yuz (100) ish kun. ammo, Bu talabnoma beruvchi tomonidan qoniqarli rioya bog'liq.