Latin America · Peru
What does it take to sell cosmetics in Peru? Entry route, responsibility, labeling
Pre-market NSO filed electronically with DIGEMID through the VUCE single window (procedur…; Responsible person: A Peruvian titular (manufacturer or importer/droguería with…; Labeling: Spanish labelling per Res.
Latest change 2025-06-24 — Andean Decision 944 (in force 2025-06-24) relaxed Spanish-translation requirements for NSO technical files and the Res. 2310 labelling regulation became mandatory 2025-12-17; the bill to ban cosmetic animal testing (PL 7688/2023-CR) cleared the Agrarian Commission in Sept 2024 but had not been passed by the plenary as of 2026. المصدر
ملخص من جهة المصنع؛ النص الرسمي هو المعتمد؛ ليس نصيحة قانونية.
- الجهة المختصة
- General Directorate of Medicines, Supplies and Drugs (DIGEMID), Ministry of Health
- اللائحة الرئيسية
- Ley 29459 (2009-11-26); DS 016-2011-SA; Decisión 833 · Law No. 29459 on Pharmaceutical Products, Medical Devices and Sanitary Products and its regulation DS 016-2011-SA, applying Andean Decision 833
- ساري المفعول
- 2009-11-26
- الدخول إلى السوق
- Pre-market NSO filed electronically with DIGEMID through the VUCE single window (procedure DGM013), valid 7 years, before import or sale.
- الشخص المسؤول
- A Peruvian titular (manufacturer or importer/droguería with DIGEMID establishment registration and a technical director) obtains the NSO and is named on the label.
- ملف السلامة
- NSO dossier per Decision 833: INCI formula, organoleptic/physico-chemical/microbiological specifications, safety and efficacy substantiation, label art and GMP/free-sale evidence.
- التسمية
- Spanish labelling per Res. 2310 with NSO code, INCI ingredients, titular, origin, lot and expiry; no fragrance-allergen declaration requirement.
- اختبارات الحيوانات
- No ban yet — bill PL 7688/2023-CR is pending before Congress.
- قوائم المكونات
- Andean Decision 833 reference lists (EU Annexes II–VI, US FDA, Mercosur) as applied by DIGEMID.
- ملاحظات
- No Peru-specific 2025–2026 cosmetics instrument was found beyond the Andean Decisions; animal-testing bill status is per reports up to April 2026.
- النص الرسمي
- https://www.digemid.minsa.gob.pe/webDigemid/normas-legales/2011/decreto-supremo-no-016-2011-sa/
FAQ
Does Peru require notification or registration before sale?
Pre-market NSO filed electronically with DIGEMID through the VUCE single window (procedure DGM013), valid 7 years, before import or sale.
Is a local responsible person mandatory in Peru?
A Peruvian titular (manufacturer or importer/droguería with DIGEMID establishment registration and a technical director) obtains the NSO and is named on the label.
What are the labeling requirements in Peru?
Spanish labelling per Res. 2310 with NSO code, INCI ingredients, titular, origin, lot and expiry; no fragrance-allergen declaration requirement.
What changed recently in Peru cosmetic regulation?
2025-06-24 Andean Decision 944 (in force 2025-06-24) relaxed Spanish-translation requirements for NSO technical files and the Res. 2310 labelling regulation became mandatory 2025-12-17; the bill to ban cosmetic animal testing (PL 7688/2023-CR) cleared the Agrarian Commission in Sept 2024 but had not been passed by the plenary as of 2026.
أسئلة المشترين ذات الصلة
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