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. ソース
工場側の概要です。正式な原文が優先されます。法的助言ではありません。
- 主管機関
- General Directorate of Medicines, Supplies and Drugs (DIGEMID), Ministry of Health
- 主要規制
- 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
- 有効
- 2009-11-26
- 市場参入
- Pre-market NSO filed electronically with DIGEMID through the VUCE single window (procedure DGM013), valid 7 years, before import or sale.
- 責任者
- A Peruvian titular (manufacturer or importer/droguería with DIGEMID establishment registration and a technical director) obtains the NSO and is named on the label.
- 安全性ファイル
- NSO dossier per Decision 833: INCI formula, organoleptic/physico-chemical/microbiological specifications, safety and efficacy substantiation, label art and GMP/free-sale evidence.
- ラベリング
- Spanish labelling per Res. 2310 with NSO code, INCI ingredients, titular, origin, lot and expiry; no fragrance-allergen declaration requirement.
- 動物実験
- No ban yet — bill PL 7688/2023-CR is pending before Congress.
- 成分表
- Andean Decision 833 reference lists (EU Annexes II–VI, US FDA, Mercosur) as applied by DIGEMID.
- 備考
- No Peru-specific 2025–2026 cosmetics instrument was found beyond the Andean Decisions; animal-testing bill status is per reports up to April 2026.
- 公式文書
- 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.
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