Test or certification item 测试或认证名称: 加拿大兽医保健品(VHP)合规备案  Veterinary Health Product (VHP) Compliance Registration in Canada

Test or certification info 测试和认证相关内容: 

兽医健康产品（VHP）是一类定位清晰的低风险兽用产品，核心用于维护和促进伴侣动物与食用动物的健康福利，明确禁止用于疾病的治疗、预防或治愈。常见品类涵盖关节补充剂、维生素矿物质补充剂、益生菌、牙科咀嚼物及外用护肤品等，其生产、进口与销售需严格遵循《食品与药品法》及配套法规要求。

Veterinary Health Products (VHP) are a well-defined category of low-risk veterinary products, primarily designed to maintain and promote the health and welfare of companion and food-producing animals. They are explicitly prohibited from being used for the treatment, prevention or cure of animal diseases. Common product categories include joint supplements, vitamin and mineral supplements, probiotics, dental chews, and topical skin care products. The production, importation and sale of VHP shall strictly comply with the Food and Drugs Act and its supporting regulatory provisions.

常见的VHP产品包括:
Common VHP products include:

关节健康类 Joint Health Category

犬用关节保健软骨素片(Joint Support Tablets for Dogs)

狗狗关节灵(Canine Joint Care Formula)

宠物关节软糖（（Hip & Joint Chews for Pets）

消化系统类 Digestive Health Category

宠物益生菌粉(Pet Probiotic Powder)

猫咪胃肠调理液(Digestive Health Liquid for Cats)

宠物消化酶咀嚼片(Digestive Enzyme Chews for Dogs and Cats)

免疫支持类 Immune Support Category

宠物维生素C液(Vitamin C Drops for Pets)

宠物免疫增强片 (Immune Support Tablets for Dogs)

宠物初乳营养补充剂(Colostrum Supplement for Pets)

口腔护理类 Oral Care Category

猫犬口腔护理喷雾(Pet Oral Spray)

宠物牙龈护理凝胶(Periodontal Gel for Cats and Dogs)

宠物口腔清洁粉(Dental Powder for Dogs)

皮毛护理类 Skin & Coat Care Category

宠物皮肤喷雾(Pet Skin Spray).

狗狗皮肤湿疹舒缓乳膏(Soothing Cream for Canine Dermatitis).

宠物鱼油软胶囊(Omega-3FishOilforDogsandCats)

 

一、 备案管理 Filing Administration

VHP实行备案管理制度，无论是本土生产还是进口产品，均需满足以下核心要求：

A filing administration system is implemented for Veterinary Health Products (VHP). Both domestically manufactured and imported products shall meet the following core requirements:

1. 备案申请及时限：首次销售且无药品识别号（DIN）的VHP，需提前至少30天向加拿大卫生部提交备案申请，获取通知编号（NN） 后方可上市；进口VHP必须提供有效的NN编号。
 Filing Application and Time Limit

For VHPs launched for the first time without a Drug Identification Number (DIN), the filing application must be submitted to Health Canada at least 30 days in advance. Such products can only be marketed after obtaining a Notification Number (NN). Imported VHPs must hold a valid Notification Number (NN).

2. 成分合规门槛：产品的所有活性成分与非活性成分，均需列入加拿大允许物质清单（PSL）；若成分未在清单内，需先单独提交成分评估申请，待录入清单后再推进VHP整体备案流程。
Ingredient Compliance Threshold

All active and inactive ingredients of the product must be listed on Canada’s Permitted Substances List (PSL). If an ingredient is not included in the list, a separate ingredient assessment application shall be submitted in advance, and the overall VHP filing process may only proceed after the ingredient is added to the list.

3. 变更备案规则：当产品品牌名、用途、剂型、适用动物等关键信息发生变更时，企业需提前30天向加拿大卫生部提交变更通知，完成备案信息更新。
Filing Rules for Changes

Where material information such as product brand name, intended use, dosage form, and target animal species is altered, the enterprise shall submit a change notification to Health Canada 30 days in advance to complete the update of filing information.

二、 适用与排除范围 Scope of Application and Exclusion

（一） 可备案为VHP的产品条件 

Eligibility Criteria for Products Registerable as VHP

1. 用途仅限维护或促进动物健康，不得涉及疾病治疗、预防与治愈；
The product is intended solely to maintain or promote animal health, and shall not be used for the treatment, prevention or cure of diseases.

2. 给药方式限定为口服、外用、耳部、牙齿/牙龈涂抹、饲料添加、鼻腔吸入；
Permitted routes of administration are limited to oral, topical, aural, dental/gingival application, feed admixture, and nasal inhalation.

3. 成分全部来源于加拿大允许物质清单；
All ingredients must be sourced exclusively from Canada’s Permitted Substances List (PSL).

4. 标签需明确标注“Veterinary Health Product/ Produit de sante animale”双语字样。
The label shall be clearly marked with the bilingual statement: Veterinary Health Product / Produit de santé animale.

（二） 禁止按VHP备案的产品类别 
Product Categories Ineligible for VHP Registration

1. 用于疾病治疗、预防、治愈的产品，以及注射、眼用、子宫内、乳腺内、植入等给药方式的产品；
Products for the treatment, prevention or cure of animal diseases; as well as products administered via injection, ophthalmic, intrauterine, intramammary or implant routes.

2. 含抗生素、激素、麻醉剂、镇静剂、驱虫剂、驱虫项圈、纳米材料、处方药的产品；
Products containing antibiotics, hormones, anesthetics, sedatives, antiparasitics, antiparasitic collars, nanomaterials, or prescription drugs.

3. 含大麻、放射性物质等受限物质的产品；
Products containing restricted substances such as cannabis and radioactive materials.

4. 宠物食品、调味品，以及多系统混合传统中药或顺势疗法与植物成分组合的产品。

Pet food and flavourings; as well as products formulated with multi-compound traditional Chinese medicine, or combinations of homeopathic and botanical ingredients.

三、 备案申请 Filing Application

备案登记申请需提交完整且规范的资料，核心内容包括：
A complete and standardized set of documentation shall be submitted for filing registration, covering the following core contents:

1. 产品基础信息：品牌名、推荐用途、目标动物、剂型、用法用量、推荐使用时长；
Basic Product Information: brand name, intended use, target animal species, dosage form, administration and dosage, and recommended duration of use.

2. 成分详细信息：每种活性与非活性成分的来源、名称、含量及用量单位，个别成分还需注明提取比例；
Detailed Ingredient Information: the source, name, content and unit of dosage for each active and inactive ingredient; the extraction ratio shall also be specified for certain ingredients.

3. 企业与合规声明：企业基本信息、GMP符合声明、不含特定风险材料（SRM）和纳米物质的声明；
Enterprise and Compliance Declaration: enterprise basic information, GMP compliance statement, and declaration that the product contains no Specified Risk Materials (SRM) nor nanosubstances.

4. 其他必备材料：标签样稿、包装规格、保存期限；安全性和有效性数据声明；若为海外企业申请，需提供加拿大代表信息。
Other Mandatory Documents: label draft, packaging specifications, shelf life; safety and efficacy data declaration. For applications submitted by overseas manufacturers, information of the Canadian representative shall be provided.

加拿大卫生部收到申请后将开展审核，通过后发放NN编号，并将产品纳入官方公开产品列表。

Health Canada will conduct a review upon receipt of the application. Once approved, a Notification Number (NN) will be issued, and the product will be included in the official public product list.

四、 标签合规 Labelling Compliance

VHP标签需严格遵循《食品与药品法》相关规定，同时满足语言与内容双重要求：
Veterinary Health Product (VHP) labels shall strictly comply with the relevant provisions of the Food and Drugs Act, and meet both linguistic and content requirements:

1. 语言强制要求：核心信息必须以英语和法语双语呈现，且法语内容需与英语内容同等清晰、准确。
Mandatory Language Requirement

Core information must be presented bilingually in English and French, with the French version equally clear and accurate as the English version.

2. 必备信息清单：需完整标注产品双语声明“Veterinary Health Product/ Produit de sante animale”；推荐用途、适用动物、剂量、使用周期；活性成分及含量（部分成分需标注来源、提取比例）、非活性成分列表；储存建议、警告语（如“孕期动物禁用”）；不良反应报告渠道与联系方式；加拿大代表信息（海外申请人适用）。
Mandatory Information List

The label shall fully display the bilingual statement: Veterinary Health Product / Produit de santé animale; intended use, target animal species, dosage and administration, and recommended period of use; active ingredients and their contents (source and extraction ratio shall be indicated for certain ingredients), as well as a list of inactive ingredients; storage instructions and precautionary warnings (e.g., “Do not use in pregnant animals”); channels and contact information for adverse reaction reporting; and details of the Canadian representative (applicable to overseas applicants).

3. 信息一致性原则：标签标注内容需与备案通知及官方在线数据库公示信息完全一致，确保真实无误导。
Information Consistency Principle

All information displayed on the label shall be identical to that stated in the filing notification and published in the official online database, ensuring authenticity and no misleading content.

五、 生产与监管  Production and Supervision

1. 生产标准：VHP生产企业需严格遵守《天然健康产品条例》第三部分的良好生产规范（GMP），保障产品质量可控。
Production Standards

VHP manufacturers shall strictly adhere to the Good Manufacturing Practices (GMP) set out in Part III of the Natural Health Products Regulations to ensure consistent and controllable product quality.

2. 不良反应上报：产品若出现严重不良反应，企业需在15天内及时上报加拿大卫生部，履行安全监测责任。
Adverse Reaction Reporting

In the event of any serious adverse reactions related to the product, the enterprise shall promptly report to Health Canada within 15 days and fulfill its obligations for safety monitoring.