Last updated: 29 September 2026.
You send a CoPP to Lima and the reply asks for the "CPF". You quote a buyer in Algeria and the tender says "AMM". A Russian distributor wants the "РУ". Pharma trade runs on a few dozen technical terms, and every market has its own words for them, sometimes different words in countries that share a language. Here are 44 of the terms that come up most in registration, quality and trade, in English, Spanish, Portuguese, French, Arabic and Russian.
Working on a deal in one of these markets?
- Buyers: post an RFQ and we'll match you with GMP-certified manufacturers who already have the right documents for your country.
- Manufacturers: list your products so importers across these regions can find you.
Three things to know before you use this
- Same language, different words. Brazil says registro and Portugal says AIM. Spain's prospecto is Latin America's inserto. In Colombia a droguería is a retail pharmacy, while in Argentina it's a wholesaler. Where it matters, we've marked the country in brackets.
- Russia and the EAEU overlap. Some terms are Russian national law, and some come from the Eurasian Economic Union's common rules. We've marked which is which.
- Arabic varies by regulator. Saudi Arabia and the Gulf, Egypt and the Maghreb don't always use the same term. We've given the common forms.
When you file anything official, use the exact wording in that regulator's own guidelines. You'll find every regulator's website in our directory of drug regulatory authorities.
Jump to: Registration and approvals · Certificates and documents · Quality and technical · Trade and deals
Registration and approvals
| English | Spanish | Portuguese | French | Arabic | Russian |
|---|---|---|---|---|---|
| Marketing authorisation (MA) The approval that lets a medicine be sold in a country. | Registro sanitario (Latin America); autorización de comercialización (Spain) | Registro sanitário (Brazil); autorização de introdução no mercado, AIM (Portugal) | Autorisation de mise sur le marché (AMM) | تسجيل المستحضر الصيدلاني / ترخيص التسويق | Государственная регистрация; регистрационное удостоверение (РУ) |
| Marketing authorisation holder (MAH) The company legally responsible for the product in that market. | Titular del registro sanitario (Latin America); titular de la autorización de comercialización (Spain) | Detentor do registro (Brazil); titular da AIM (Portugal) | Titulaire de l'AMM | حامل ترخيص التسويق / صاحب التسجيل | Держатель регистрационного удостоверения |
| Common Technical Document (CTD) The standard dossier format. ASEAN uses its own version, the ACTD. | Documento Técnico Común (DTC) | Documento Técnico Comum (DTC) | Document technique commun (DTC) | الوثيقة الفنية الموحدة (CTD) | Общий технический документ (ОТД) |
| Registration dossier | Expediente de registro | Dossiê de registro (Brazil); processo de AIM (Portugal) | Dossier d'AMM / dossier d'enregistrement | ملف التسجيل | Регистрационное досье |
| Variation (post-approval change) | Modificación / variación | Alteração pós-registro (Brazil); alteração dos termos da AIM (Portugal) | Modification (variation) de l'AMM | تعديل ما بعد التسجيل | Внесение изменений в регистрационное досье |
| Renewal of registration | Renovación del registro sanitario | Renovação do registro (Brazil); renovação da AIM (Portugal) | Renouvellement de l'AMM | تجديد التسجيل | Подтверждение регистрации (EAEU / Russia) |
| Reliance / abridged route Faster approval based on a reference regulator's decision. | Procedimiento abreviado; reliance regulatorio | Via abreviada; via otimizada (ANVISA) | Procédure abrégée; reliance réglementaire | المسار المختصر / الاعتماد التنظيمي | Ускоренная процедура; процедура взаимного признания (EAEU) |
| Named-patient / special import Importing an unregistered medicine for a specific patient. | Importación excepcional / uso compasivo | Importação excepcional | Importation exceptionnelle / accès compassionnel | استيراد استثنائي لمريض محدد | Ввоз незарегистрированного препарата для конкретного пациента |
| Local agent / legal representative Many countries require a local company to hold or manage the registration. | Representante legal / apoderado | Representante legal | Représentant local; exploitant (France) | الوكيل المحلي | Представитель держателя регистрационного удостоверения |
Certificates and documents
| English | Spanish | Portuguese | French | Arabic | Russian |
|---|---|---|---|---|---|
| Certificate of Pharmaceutical Product (CoPP) WHO-format certificate issued by the exporting country's regulator. | Certificado de Producto Farmacéutico (CPF) | Certificado de Produto Farmacêutico | Certificat de produit pharmaceutique (CPP) | شهادة المستحضر الصيدلاني (CPP) | Сертификат фармацевтического продукта (СФП) |
| Free Sale Certificate (FSC) | Certificado de Libre Venta (CLV) | Certificado de Livre Venda (CLV) | Certificat de libre vente (CLV) | شهادة البيع الحر | Сертификат свободной продажи |
| GMP certificate Russia (Minpromtorg) issues a GMP conclusion; the EAEU issues its own GMP certificate. | Certificado de Buenas Prácticas de Manufactura, BPM (Colombia, Peru, Central America); de Fabricación, BPF (Spain, Mexico, Argentina) | Certificado de Boas Práticas de Fabricação, CBPF (Brazil); certificado de Boas Práticas de Fabrico (Portugal) | Certificat de Bonnes Pratiques de Fabrication (BPF) | شهادة أسس / ممارسات التصنيع الجيد (GMP) | Сертификат GMP; заключение о соответствии требованиям надлежащей производственной практики |
| Manufacturing licence | Licencia de fabricación / licencia sanitaria de funcionamiento | Autorização de Funcionamento (AFE) e Licença Sanitária (Brazil) | Autorisation d'ouverture d'établissement pharmaceutique fabricant | ترخيص مصنع الأدوية | Лицензия на производство лекарственных средств |
| Certificate of Analysis (CoA) | Certificado de análisis | Certificado de análise | Certificat d'analyse | شهادة التحليل | Сертификат анализа |
| Summary of Product Characteristics (SmPC) | Ficha técnica (Spain); información para prescribir, IPP (Mexico, Colombia) | Resumo das Características do Medicamento, RCM (Portugal); bula para o profissional (Brazil) | Résumé des caractéristiques du produit (RCP) | ملخص خصائص المستحضر | Общая характеристика лекарственного препарата (ОХЛП) |
| Patient information leaflet (PIL) | Prospecto (Spain); inserto / instructivo (Latin America) | Bula (Brazil); folheto informativo (Portugal) | Notice | النشرة الداخلية | Листок-вкладыш (EAEU); инструкция по медицинскому применению (Russia) |
| Legalisation / apostille Many markets need certificates legalised by their embassy. | Legalización / apostilla | Legalização / apostila | Légalisation / apostille | التصديق / الأبوستيل | Легализация / апостиль |
| Letter of authorisation (LoA) Lets an importer or agent act for the manufacturer. | Carta de autorización | Carta de autorização | Lettre d'autorisation | خطاب تفويض | Авторизационное письмо |
Quality and technical
| English | Spanish | Portuguese | French | Arabic | Russian |
|---|---|---|---|---|---|
| Active pharmaceutical ingredient (API) | Principio activo; ingrediente farmacéutico activo (IFA) | Insumo farmacêutico ativo, IFA (Brazil); substância ativa (Portugal) | Substance active; principe actif | المادة الفعالة | Фармацевтическая субстанция; активная фармацевтическая субстанция (АФС) |
| Excipient | Excipiente | Excipiente | Excipient | سواغ / المواد غير الفعالة | Вспомогательное вещество |
| Finished product | Producto terminado | Produto acabado | Produit fini | المستحضر النهائي | Готовый лекарственный препарат |
| Ready-to-fill bulk Product made but not yet packed, often supplied for local packing. | Producto a granel | Produto a granel | Produit en vrac | المنتج السائب / المستحضر غير المعبأ (Bulk) | Продукция in bulk; нерасфасованная продукция |
| Generic medicine | Medicamento genérico | Medicamento genérico | Médicament générique | دواء جنيس (GCC, Maghreb) / دواء مثيل (Egypt) | Воспроизведённый лекарственный препарат (дженерик) |
| Reference (innovator) medicine | Medicamento de referencia | Medicamento de referência | Médicament de référence (princeps) | المستحضر المرجعي | Референтный лекарственный препарат |
| Biosimilar | Biosimilar; medicamento biotecnológico similar | Biossimilar | Biosimilaire | مستحضر حيوي مماثل (مثيل حيوي) | Биоаналоговый (биоподобный) лекарственный препарат |
| Bioequivalence study | Estudio de bioequivalencia | Estudo de bioequivalência | Étude de bioéquivalence | دراسة التكافؤ الحيوي | Исследование биоэквивалентности |
| Stability study | Estudio de estabilidad | Estudo de estabilidade | Étude de stabilité | دراسة الثبات | Исследование стабильности |
| Shelf life | Vida útil (Latin America); período de validez (Spain) | Prazo de validade | Durée de conservation | مدة الصلاحية | Срок годности |
| Batch / lot | Lote | Lote | Lot | التشغيلة | Серия |
| Batch release | Liberación de lotes | Liberação de lotes (Brazil); libertação de lotes (Portugal) | Libération des lots | الإفراج عن التشغيلة | Выпуск серии |
| Primary / secondary packaging | Envase primario / secundario (Latin America); acondicionamiento primario / embalaje exterior (Spain) | Embalagem primária / secundária (Brazil); acondicionamento primário / embalagem exterior (Portugal) | Conditionnement primaire / extérieur | العبوة الأولية / الثانوية | Первичная / вторичная упаковка |
| Pharmacovigilance | Farmacovigilancia | Farmacovigilância | Pharmacovigilance | اليقظة الدوائية (Egypt, Maghreb); التيقظ الدوائي (GCC) | Фармаконадзор |
| Good Distribution Practice (GDP) | Buenas Prácticas de Distribución | Boas Práticas de Distribuição, Armazenagem e Transporte (Brazil); Boas Práticas de Distribuição (Portugal) | Bonnes pratiques de distribution (BPD); bonnes pratiques de distribution en gros, BPDG (France) | ممارسات التوزيع الجيد؛ أسس التخزين والتوزيع الجيد (Saudi Arabia) | Надлежащая дистрибьюторская практика |
| Cold chain | Cadena de frío | Cadeia de frio | Chaîne du froid | سلسلة التبريد | Холодовая цепь |
Trade and deals
| English | Spanish | Portuguese | French | Arabic | Russian |
|---|---|---|---|---|---|
| Public tender | Licitación pública | Licitação pública; pregão (Brazil) | Appel d'offres | مناقصة حكومية | Государственная закупка (тендер) |
| Import permit | Permiso de importación | Licença de importação (Brazil); autorização de importação (Portugal) | Autorisation d'importation | إذن الاستيراد | Разрешение на ввоз |
| Wholesale / distribution licence | Autorización de distribuidor mayorista; droguería (Argentina, Peru); almacén mayorista (Spain) | Autorização de Funcionamento para distribuidora (Brazil); autorização de distribuição por grosso (Portugal) | Autorisation d'ouverture d'établissement pharmaceutique distributeur en gros (France, Maghreb); autorisation de distribution en gros (Belgium) | ترخيص مستودع أدوية | Лицензия на фармацевтическую деятельность (оптовая торговля) |
| Proforma invoice | Factura proforma | Fatura proforma | Facture pro forma | فاتورة مبدئية | Счёт-проформа |
| Letter of credit (L/C) | Carta de crédito | Carta de crédito | Crédit documentaire | اعتماد مستندي | Аккредитив |
| Minimum order quantity (MOQ) | Cantidad mínima de pedido | Quantidade mínima de pedido | Quantité minimale de commande | الحد الأدنى للطلب | Минимальный объём заказа |
| Contract manufacturing | Fabricación por contrato; maquila (Mexico, Central America) | Fabricação terceirizada (Brazil); fabrico por contrato (Portugal) | Fabrication à façon | التصنيع التعاقدي (التصنيع لدى الغير) | Контрактное производство |
| Technology transfer | Transferencia de tecnología | Transferência de tecnologia | Transfert de technologie | نقل التقنية | Трансфер технологий |
| Licensing agreement | Contrato de licencia | Contrato de licenciamento | Accord de licence | اتفاقية ترخيص | Лицензионное соглашение |
| Exclusive distributor | Distribuidor exclusivo | Distribuidor exclusivo | Distributeur exclusif | موزع حصري | Эксклюзивный дистрибьютор |
Where to go next
- Drug regulatory authorities of the world: websites, registers and portals for 200+ regulators.
- Import guides by region: what each country requires, in plain words.
- CTD vs ACTD and CEP vs DMF vs ASMF.
Think we've got a term wrong for your market, or missed one you use every day? Email bd@pharmatradz.com and we'll add it.
Terms reflect common regulatory and trade usage (for example ANVISA, INFARMED, ANSM, AEMPS, COFEPRIS, SFDA, EDA, and Russian and EAEU rules) as of September 2026. Always check the regulator's current guidelines before filing.
