CRED ERP 25

07/07/2025

SCOPE OF CENTRALISED PROCEDURE

The centralised procedure is compulsory for:

1) human medicines containing a new active substance to treat: ❖ human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS); ❖ cancer; ❖ diabetes; ❖ neurodegenerative diseases; ❖ autoimmune and other immune dysfunctions; ❖ viral diseases.[1]

2)medicines derived from biotechnology processes, such as genetic engineering;

3)Advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;

4)orphan medicines (medicines for rare diseases);

5)veterinary medicines for use as growth or yield enhancers.

It is optional for other medicines:

❖ containing new active substances for indications other than those stated above; ❖ that are a significant therapeutic, scientific or technical innovation; ❖ whose authorisation would be in the interest of public or animal health at EU level.[1]

The Organisation for Professionals in Regulatory Affairs

3

STEPS PRIOR TO SUBMITTING AN APPLICATION

● SUBMISSION OF ELIGIBILITY REQUEST

To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the specific form and accompanied by a justification. When: 18 to 7 months before submission of marketing authorisation application [1].

● NOTIFICATION OF INTENTION TO SUBMIT AN APPLICATION

Update: To notify the Agency of the intended submission date, applicants should send the pre submission request form via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Letter of Intent Request'.[1]

When: 7 months before submission of marketing authorisation application

The Organisation for Professionals in Regulatory Affairs

4

2