Module 12 2019

Marketing Authorisation Application

maa

Variation Type IAIN

var-type1ain

Repeat Use Procedure in decentralised or mutual recognition procedures to include one or more additional member states

rup

Periodic Safety Update Report (PSUR) which should only be used for PSURs outside of the PSUSA

psur

PSUR single assessment procedure

psusa

Specific obligation related to a post-authorization measurepam-anx = Annex II condition related to a post-authorisation measure

pam-sob

Additional pharmacovigilance activity in the risk-management plan related to a post-authorisation measures (RMP) (e.g. interim results of imposed/non-imposed interventional/non-interventional clinical or nonclinical studies)

pam-mea

Legally binding measure related to a post-authorisation measures

pam-leg pam-sda pam-capa pam-p45 pam-p46 pam-paes pam-rec

Cumulative review following a request originating from a PSUR or a signal evaluation related to a post-authorisation measure

Corrective Action/Preventive Action related to a postauthorisation measure Paediatric submissions related to a post-authorisation measure Paediatric submissions related to a post-authorisation measure

Submission of a post authorisation efficacy study

Recommendation related to a post-authorisation measures e.g. quality improvement related to a post-authorisation measure

Submission of a post authorisation safety study protocol (according article 107n) Submission of a post authorisation safety study report (according article 107q)

pass107n pass107q referral-20 referral-294 referral-29p referral-30 referral-31 referral-35 referral-5-3 referral-107i referral-16c1c referral-16c4 clin-data-pub-rp clin-data-pub-fv

Referral under Article 20

Referral under Article 29(4)

Referral under Article 29 paediatric Referral under Article 30 Referral under Article 31 Referral under Article 35 Referral under Article 5(3) Referral under Article 107i Referral under Article 16c (1c)i Referral under Article 16c(4)

Clinical data for publication – Redacted Proposal

Clinical data for publication – Final Version

Paediatric submission related to a paediatric investigational plan according to article 7, 8 or 30 of the Regulation

paed-7-8-30

Paediatric submission post approval once a paediatric investigational plan has been performed

paed-29

Paediatric submission according to article 45 of the Regulation

paed-45

Withdrawal of a marketing authorisation in regard to a strength or form or entirely. This submission type shall not be used to withdraw a regulatory activity.

withdrawal

Submission that applies to an application on a Certificate of suitability CEP application (EDQM only).

cep

The Organisation for Professionals in Regulatory Affairs

In the exceptional case of reformatting the application no regulatory activity is allowed. Therefore, ‘none’ must be stated. The submission application unit will identify the sub-activity related to the product. In the submission description some information can be provided to e.g. highlight specific modules being reformatted

none