Timeline Calendar Markets

MS Connected calendar

Month Year

Mon

Tue

Wed

Thu

Fri

Sat

Sun

Procedure's geographies 0 active countries

1-2 active procedures 3-4 active procedures 5+ active procedures

Recent files

File name	Product	Date added	Modified at	Status

Tasks this week

Regulatory News

Workload per user: Capacity vs ongoing procedures

Correlation between available team FTE and active procedure workload. Each procedure row reflects per-person load in the 0.5 to 1.3 FTE/day range.

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FTE settings Team settings Workdload settings

Team size 3 FTE

Average available FTE -

Average workload -

Peak overload -

Workload from active procedures (FTE/day) Available team capacity (FTE/day) Overload area (workload above capacity)

Fees & budget status

On track: budget spent as planned

May fees 55,543.33 EUR

Year until now 187,854.03 EUR

Remaining budget for 2026 255,765.99 EUR

Procedure number	Product	Owner	Active window	Daily load

Deadlines and ownership watchlist

Overdue tasks -

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Deadlines this week -

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Procedures approaching deadlines this quarter -

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Tasks without owners due in next 90 days

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Brand name

Strength

Dosage form

Select dosage form Tablets (immediate, delayed, or extended-release) Capsules (hard-shell or soft-gel) Solutions Suspensions Syrups Elixirs Powders and Granules Lozenges and Troches

Route of administration

Oral Sublingual Buccal Rectal Transdermal Inhalation Intranasal Ophthalmic Otic Vaginal Cutaneous/Topical (creams/gels)

Pack sizes

Therapeutic area

ATC code

Product category

MAH

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, Poland

Manufacturer (finished product)

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław, Poland

APIs

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Internal product code

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Product Metadata

Ongoing procedures

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Product Documents

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Packaging data

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Procedure number	Brand name (RMS in DCP)	Procedure type	Legal basis	Owner	Description	Submission date	Status	Deficiency Letter Deadline	Implementation Deadline

Create New Procedure

Process type *

Select process type New MAA Variation Annual fee Renewal MAH transfer

Procedure number *

Brand name (RMS in DCP) *

Procedure type *

Select procedure type Centralised Procedure (CP) Decentralised Procedure (DCP) Mutual Recognition Procedure (MRP) National Procedure Repeat Use Procedure

DCP/MRP countries *

RMS (main country) *

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CMS countries (secondary) *

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Legal basis *

Select legal basis Full application — First-time application for a new product Line Extension — New strength, form, or route of an existing MA Generic Application — Article 10(1) — reliance on reference product Hybrid Application — Article 10(3) — mixed data package Well-established use — Article 10a — bibliographic application - no RMP in Europe Fixed combination — Article 10b Informed consent — Article 10c — reliance on existing MA holder's data

Owner *

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Local representatives

Description *

Submission date (planned)

Application fee reference

eCTD sequence number

eSubmission gateway

Select gateway CESP National gateway EMA gateway

Status *

Select status Planned In preparation Submitted Ongoing Approved Rejected Withdrawn

Deficiency Letter Deadline

Implementation Deadline

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Procedure Details

Planned In preparation Submitted Ongoing Approved Rejected Withdrawn

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Procedure number

Brand name

Procedure type

Centralised Procedure (CP) Decentralised Procedure (DCP) Mutual Recognition Procedure (MRP) National Procedure Repeat Use Procedure

Process type

New MAA Variation Annual fee Renewal MAH transfer

Legal basis

Full application Line Extension Generic Application Hybrid Application Well-established use Fixed combination Informed consent

Owner

Description

Submission date

eSubmission gateway

Select gateway CESP National gateway EMA gateway

eCTD sequence number

Deficiency Letter Deadline

Implementation Deadline

RMS country

CMS countries (comma separated)

Procedure timeline

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Ticket	Section	Product area	Team	Task	Assignee	Status

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Procedure number	Country	Brand name	API	MA Number	Registration Date	Validity	Owner	MAH	Actions

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Procedure number

Country

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Brand name

API (Active Pharmaceutical Ingredient)

MA Number

Registration Date

Validity

Select validity period 5 Years Unlimited 1 Year (Conditional) Pending

Owner (User)

MAH (Marketing Authorization Holder)

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Active substance	Manufacturer	Manufacturer country	API Documentation number

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MAH Legal name	Country	Contact person

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User Access Matrix

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Granular permission matrix

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