两段有关外观的EMA 指南文字，摘录如下，供参考：

1. 仿制药与原研药应有相同特征？ 

It is not mandatory for a generic product to have the same characteristics as the innovator (e.g. in terms of colour, size and shape of the tablet or capsule), however this may reduce the risk of medication errors at the dispensing stage. There is also some evidence that variation in the appearance of marketed or generic products can lead to patients discontinuing essential treatment early. <Good practice guide on risk minimisation and prevention of medication errors EMA/606103/2014 Final 2015>

2. 相同MA，相同规格片剂，可否有不同外观？

Is it acceptable to propose two different appearances (shape, dimensions, colour) for a single strength tablet in a single Marketing Authorisation? H+V April 2014 <Quality of medicines questions and answers: Part 2>

The QWP considers that two different tablet appearances (tablet shape, dimensions or colour) of the same product (same name, same packaging details, same marketing authorisation number) may confuse patients (or users of veterinary medicinal products). Such confusion is considered to have a negative effect on therapeutic adherence and therefore considered as a risk to public and/or animal health. Acceptance of such different tablet appearances in the specification of a single strength product would formally also allow the company to dispense these two appearances in the same container/blister, which may even cause greater confusion. In addition, it is not clear to which extent such different appearances would have an effect on patient / user acceptability.

Moreover, the introduction to the variation classification guidelines (2013/C 223/01) includes the following statement: "References in this Annex to changes to the marketing authorisation dossier mean addition, replacement or deletion, unless specifically indicated." For the purpose of illustration and comparison, change code B.II.a.1 (Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.) includes specific reference to addition, which means that tablet markings can be added if not currently present. However, change code B.II.a.2 (Change in the shape or dimensions of the pharmaceutical form) does not include any reference to addition. Therefore, in view of this specific absence and taking into account the highlighted introductory text, this could be interpreted as meaning that any change to the shape or dimensions of the pharmaceutical form cannot include the addition of an additional/alternative shape but only replacement. This is also true for A.2 (Change in the (invented) name of the medicinal product) where only a change is referred to and where only replacement is possible.

建议结合FDA 指南Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules （2015）一并考虑。

综上，从依从性和防止用药错误的角度考虑，应尽量相似，但能否相同，还要兼顾是否有外观专利侵权的风险。