We are often asked whether selling in Japan requires a government review. For cosmetics, there is as a rule no product-by-product approval. The system does not put the product through a review; it has you file a notification.
The notification has a deadline, however, and that deadline sits before customs clearance. And what is actually scrutinised on the form is not the ingredients but the product name. The previous article dealt with the ingredient names on the container, so this one takes the procedure that comes before it, article by article.
Approval is the exception; notification is the rule
Article 14(1) of the Act requires product-by-product approval for cosmetics containing ingredients designated by the Minister. What that designation is, is the non-disclosed ingredient covered in the previous article. You enter the world of approval only if you choose not to put an ingredient name on the container.
Every other cosmetic — which is to say almost all of them — has no approval. Article 14-9 provides instead:
When a marketing authorisation holder of pharmaceuticals, quasi-drugs or cosmetics intends to market pharmaceuticals, quasi-drugs or cosmetics other than those provided for in Article 14(1), it shall notify the Minister of Health, Labour and Welfare to that effect in advance, product by product, as provided by ministerial ordinance.
Three words carry the weight. In advance (not after shipping), product by product (separate from the company licence), and a change to a notified particular must be notified within 30 days (paragraph 2 of the same article). Every reformulation and every relaunch generates paperwork.
Where it goes, and by when
The notification is filed under Article 70 of the Enforcement Regulation on Form 39, and changes on Form 40. For cosmetics the recipient is not the Pharmaceuticals and Medical Devices Agency, as it is for pharmaceuticals, but the governor of the prefecture where the office of the marketing supervisor-general is located (薬食審査発第0331015号). Move the office and the recipient moves with it.
The real deadline is written in a different article: Article 94 of the Enforcement Regulation.
A marketing authorisation holder intending to import pharmaceuticals, quasi-drugs or cosmetics in the course of business for the purpose of marketing shall, by the time of customs clearance, hold a document, or a copy of one, evidencing that one of the following has been carried out with respect to the item to be imported.
What follows is a list: an approval, an application for approval, or the notification under Article 14-9. Seen from the importer's side, then, the notification must be finished not "before selling" but "by customs clearance". Fix the shipping schedule first and the goods sit at the port.
What you do not write on the form
The content of the form surprises people. For cosmetics, the following fields may be filled in as "omitted".
- Ingredients and quantities, or essential nature
- Dosage and administration
- Efficacy or effect
- Storage method and shelf life
- Specifications and test methods
In other words, this notification does not review the formulation. Whether the formulation complies with the standard is, exactly as with the full-ingredient declaration in the previous article, for the company to verify on its own responsibility. A notification accepted is not a formulation approved.
Some fields, on the other hand, must be filled. For manufacturing sites, you list every licensed site plus every foreign marketing authorisation holder and foreign manufacturer notified on Form 115. If you import, you state so in the remarks field, and you also put the product name used in the country of origin in the remarks.
The product name is where the substance is
Among all those fields that may be omitted, the one that comes with detailed drafting rules is the product name. First, how to treat a range that differs only in colour or scent.
State the product name (where a case in which the product name excluding the part indicating colour or scent is the same, and properties other than colour or scent do not differ significantly — hereinafter a "series product" — is notified as one product, this means the name excluding the part identifying colour or scent, such as the colour number, colour name or scent name).
Twenty lipstick shades differing only by colour number need not be notified as twenty products. They can be grouped as one series product, with "series" written in the remarks field.
There is a constraint running the other way too: do not use the same product name for products of different formulations. Increases or decreases in ingredients within a range that does not significantly alter the properties are acceptable under the same name, provided no confusion arises in marketing or use. When a relaunch changes the contents but keeps the name, you are deciding which side of that line you are on.
9 things a product name must not do
薬食審査発第0331015号 asks for attention to the following further points.
- Do not use a name identical to an existing pharmaceutical or quasi-drug
- Do not use a false, exaggerated or potentially misleading name
- Do not use the name of a specific ingredient contained in the product
- Do not use a name consisting only of Roman letters
- Keep letters, numerals and symbols to a minimum
- Do not use a name inconsistent with the dosage form
- Do not use a name over which another company clearly holds a trademark
- Do not use a name conflicting with the fair competition code on cosmetics labelling
- Do not use a name liable to be confused with a pharmaceutical or quasi-drug (e.g. "… medicine", 薬用…, "Kampo …", "Medical …", "… agent", "atopy …", "acne …", "allergy …")
Imported brands most often collide with the third, fourth and ninth: a name built on an ingredient, a name in Latin letters only, and a name containing 薬用 ("medicated") or "medical". All three are ordinary usage outside Japan.
If the name is judged inappropriate, a change is required at the notification-review stage. Renaming after the labels and cartons have been ordered is the most expensive version of this fix, so the safest place for the product name is at the very front of the schedule.
The order to work in before you order printing
Taking the previous article together with this one, the items to settle before going to print fall in this order.
- Confirm the category — cosmetic or quasi-drug
- Choose candidate product names and check them against the nine points above (query the competent prefectural division if needed)
- Decide whether to group as a series product or split into separate items
- Map every ingredient to its Japanese display name, and build the order and the allowances into the design
- File the marketing notification — and if importing, complete it by the time of customs clearance
- Only then order labels and cartons, and fix the shipping schedule
A considerable amount of loss in this field disappears simply by keeping the procedure in order. Name and notification first; printing and shipping after. Reverse them and both have to be redone.
Primary sources
- Pharmaceuticals and Medical Devices Act, Article 14(1) and Article 14-9 (e-Gov law search)
- Enforcement Regulation, Article 70 (notification of marketing) and Article 94 (procedures for importation for marketing)
- Handling of pharmaceuticals etc. not requiring marketing approval upon entry into force of the revised Pharmaceutical Affairs Act (薬食審査発第0331015号, 31 March 2005) / published by Chiba Prefecture
* This article outlines the system. Individual determinations, including whether a product name is acceptable, rest with the competent prefectural pharmaceutical affairs division. The transitional provisions are not quoted here.
We import and wholesale cosmetics and quasi-drugs, and we plan the product name, the notification and the labelling as a single schedule. We are glad to be consulted from the product-selection stage onwards.
