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September: Record an item of gratitude daily. We have received the Holy Spirit in Baptism and Confirmation. We come to know more fully who the Holy Spirit is and how we need to surrender ourselves to Him and allow Him to guide and define our lives so we can live the life we have been called to live and be the person God created us to be.

Anyone who feels they are missing something in their life. Anyone who wants a deeper walk with Jesus. Anyone who is searching for a deeper understanding of the love of God and the empowerment of the Holy Spirit.

April: We receive the Divine Mercy of God through Confession March: Entrust yourself to God before going to sleep February: Pray for the person who is the most difficult or distant to you each day January: Give the first 10 minutes of each day to God.

If you have any questions, please contact the parish office. We step with the foot of charity when we work to assist others with their immediate, short-term needs.

We step with the foot of justice when we work to address the root causes of problems facing our communities. Our Stephen Ministers were selected for this award because of their participation in championing diversity in the community.

Our Stephen Ministers, serve parishioners as well as people in the surrounding communities. Their open, non -judgmental and loving presence to those who are going through a difficult time helps bring healing and is a wonderful example of evangelization.

By bestowing this commendation to our Stephen Ministry program, the City of Sterling Heights is recognizing the great gifts of this caring ministry.

Congratulations Stephen Ministers! We are so proud of all of you! Let all souls draw life from it. Are You Stressed? Feeling Down? Our Stephen Ministers are ready to provide you with confidential, one-to-one, Christian care and support to help you get through a tough time.

Our Stephen Ministers are there to care. Lawrence Catholic Church at Please, prayerfully consider helping us reach our goal!

As we approach year-end, many parishioners make their final contributions to the Parish in the closing weeks of the year.

Perhaps you might consider designating a portion of your offerings towards the CSA. Lawrence Parish must meet this pledge commitment either through direct pledges or from its operating budget.

For those who have already donated, perhaps you might consider an additional offering. You may simply designate on an envelope or the check itself CSA Appeal or if you prefer a pledge card can be obtained from the Parish Office and included with your offering.

Contributions can be placed in the collection basket, hand-delivered or mailed to the parish office directly.

Thank you St. Lawrence Parishioners for your continued support of this annual appeal and the multitude of ministries that it supports throughout the Archdiocese of Detroit!

For us, the message about the annunciation is clear. Mary responded to the angel with openness and trust. As your family lights all of the candles on the Advent wreath this week, offer the following prayer: Lord, hurry and come to us.

May your light shine in our lives, so that we may be freed from sin. Protect us from all anxiety as we wait in joyful hope for your coming as our Savior.

Amen Merry Christmas to you and your family. God bless you. Lawrence Families a very Blessed Merry Christmas!

Let us celebrate Christmas with a prayer of expectation not for worldly joys and gifts; but for the joys and gifts of the Holy Spirit.

Let all of us realize the importance of the Holy Spirit within our lives and accept Him into our lives. It is only through total surrender to the Holy Spirit that we can have the Spiritual strength to lead a truly faithful life with God.

Come to the Holy Spirit this New Year and realize your great expectations. You are invited to attend a tranquil weekend of spiritual reflection and renewal for men.

Join us for a weekend at the Capuchin Retreat on 95 wooded acres adjacent to the Stony Creek Nature Center to: relax from a hectic schedule, enjoy nature, make new friends, reflect on our situation in life and above all, to reopen and strengthen our lines of communication with God.

Bring a friend! Vernon Rd. North of 28 Mile Rd. Washington, MI www. Weekend includes lodging, conferences, a Friday evening snack and five excellent meals.

Capacity is limited so please call Paul Okoniewski to confirm your reservation. See one of our Ushers for more information. This week we pray with peace.

Scripture tells us that God keeps His promises. Like Mary, we can respond to God with peaceful confidence in His love for us in all circumstances.

Question of the Week: Is there something hard you need to do this week? What might make it easier? Important CRE Dec.

Families who are interested in half-day 3-year old Nursery School, half-day or full-day 4-year old Preschool, half-day or full-day Kindergarten through Eighth Grade are encouraged to attend.

Administrators, teachers, current parents and students will be available to answer questions. Tours will be offered for new families as well.

Interested families who are unable to attend the Open House may call the St. Lawrence Catholic School Office at to schedule a tour and receive an informational packet.

Registration application forms for Nursery School - Grade 8 will be available on the school website beginning January 25 www.

Lawrence Catholic School should complete an application and return it to the school office between the above registration dates.

New family applications from families belonging to St. Lawrence Parish will be put in acceptance order based on length of membership in the parish.

New family applications from those belonging to other parishes will be taken on a first come, first served basis beginning at January After February 4 the official end of the registration period , applications will be put in acceptance order according to the date of receipt of application regardless of parish affiliation.

Bus service is provided to all in the Utica Community School District. Latchkey is available before and after school to Kindergarteners through eighth graders.

For more information, contact the school at You do not have to stay the entire 3 hours, but please come and spend some one on one time with our Lord.

You will receive a new lector workbook and become adept at using the church sound system. Please contact Eileen Martini at or Kathy Padley at if you have any questions.

On February 14th, we will have the Mass for the living and deceased members of the Altar Society at pm. In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the 'reference authority'.

Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August In order to benefit from a worksharing procedure, it is required that the same changes will apply to the different medicinal products concerned, with either no or limited need for assessment of a potential product-specific impact.

Therefore, where the 'same' changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product-specific assessment, such changes will not benefit from worksharing.

Grouped variations can be subject to a worksharing procedure, provided that the same group of variations applies to all medicinal products concerned by the worksharing procedure.

Examples of changes which would be considered suitable for evaluation under worksharing :. In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency at least two months in advance of the submission of a variation or group of variations to be subject to a worksharing procedure, together with an explanation as to why the holder believes that a worksharing procedure is suitable, by means of a 'letter of intent'.

A letter of intent template is available. The letter should be sent to pa-bus ema. Upon receipt of the letter of intent, the Product Lead if the worksharing procedure contains at least one Type II variation will review and decide whether the proposed worksharing procedure is acceptable.

Subsequently, the Agency will initiate the Rapporteur appointment procedure. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application includes a new indication for the procedure.

It is expected that the co- rapporteur will be one of the rapporteurs of the centrally authorised medicinal products or a CHMP member representing one of the RMSs or national competent authorities for the nationally authorised products.

The MAH will be informed accordingly. Worksharing procedure for multiple centrally authorised medicinal products 'duplicates'.

Marketing Authorisation Holders are advised to submit such variations as usual. The submission requirements as set out in the post-authorisation-guidance sections for the different types of variations will also apply to variations subject to worksharing , but the application should be provided as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for.

This will include a cover letter and electronic application form, together with separate supportive documentation for each medicinal product concerned and revised product information if applicable for each medicinal product concerned.

The worksharing application must be submitted at the same time to all relevant authorities, i. From 1 March , the use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure.

This applies to all applications for human medicines. Applicants must not send any accompanying hard media or separate paper cover letter as the cover letter will be in the relevant part of eCTD module 1 in PDF format.

Where applicable, revised product information Annexes including Annex A, if applicable should be included in electronic Word and PDF format in the same eSubmission Gateway or eSubmission Web Client package within a folder called 'working documents'.

Where applicable changes in Word documents should be indicated using 'Tools-Track Changes'. Clean PDF versions should have all changes 'accepted'.

An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. For nationally authorised medicinal products eCTD mandatory.

Paper submissions are not accepted. Submission to the National Competent Authorities. Submission to the Rapporteur and Committee members.

The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. For a full overview of dossier requirements for National Competent Authorities of Co- Rapporteur and Committee members, including delivery addresses, please refer to the following document: Dossier requirements for Centrally Authorised Products CAPs.

The Agency will allocate a 'high-level' cross-products procedure number, which will be used for the handling of worksharing procedures affecting more than one medicinal product.

A new procedure code abbreviation is used for worksharing procedures i. For all worksharing procedures, including those which contain nationally authorised medicinal products , the 'high-level' procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: PA-BUS ema.

The MAH must submit the variation application for worksharing at the latest by the recommended submission dates published under submission dates.

In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles as those applied to the assessment of Type II variations.

The day period may be reduced having regard to the urgency of the matter, particularly for safety issues, or may be extended to 90 days for Type II variations concerning changes or additions to the therapeutic indication.

Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure.

Such opinions will also list any variations e. The same general principles as for grouped variations applies.

See grouping of variations: questions and answers. Schematic structure of the CHMP opinion and annexes for an application under worksharing , consisting of centrally and nationally authorised medicinal products :.

Upon adoption of the CHMP opinion on the worksharing procedure, the Agency will inform the MAH and Member States concerned if applicable as to whether the opinion is favourable or unfavourable including the grounds for the unfavourable outcome , as well as whether the Commission decision granting the Union marketing authorisations requires any amendments.

Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly.

This means that the MAH may give written notice to the Agency or CHMP that it wishes to request a re-examination within 15 days of receipt of the opinion after which, if it does not appeal, the opinion will be considered final.

The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion.

If the MAH requests that the Committee consult a scientific advisory group in connection with the re-examination , the applicant should inform the CHMP as soon as possible.

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